Resonance G34109Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10827002341095), received between Sep 6, 2016 and Jan 7, 2026 — classified as 19 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Material Twisted/Bent; Activation Failure

  CANCELLATION REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-FEB-2026. AT WHAT POINT IN THE PROCEDURE DID THE STENT KINK? - DIRECTLY AFTER THE ORIFICE. WHAT TYPE AND SIZE WIRE GUIDE WAS USED WITH THE DEVICE? - UROS-035150-S. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. - KIDNEY, URETER, BLADDER. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G., KINK)? - NO. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? - SAME DAY, SAME PROCEDURE. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? - WOLF CYSTOSCOPE 21 CH. WAS THE STENT STORED IN STRONG LIGHT E.G., IN A PYRIX MACHINE OR DIRECT SUNLIGHT? - NO, I BROUGHT THE STENT AS REP STOCK. HOW DID THE PHYSICIAN DETERMINE THE LENGTH OF THE STENT TO BE USED FOR THE PROCEDURE? - IT WAS A RESONANCE CHANGE, SO THE SIZE WAS NOT UNKNOWN. BUT UPG WAS NORMAL. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE INTO POSITION? - NO. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCTION SYSTEM INTO POSITION? - NO. WAS RESISTANCE ENCOUNTERED WHEN ADVANC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989454 ↗
• MalfunctionJun 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT: A 22 CM RESONANCE STENT WAS ATTEMPTED TO BE PLACED AND DURING PLACEMENT A GUIDEWIRE BECAME "JAMMED" IN THE STENT AND THE STENT COULDN'T BE PLACED. THE STENT AND GUIDEWIRE WERE DISCARDED. NO DAMAGE TO THE PATIENT WAS NOTED. ANOTHER 22CM RESONANCE STENT (LOT NUMBER C2114313) WAS OPENED AND PLACED WITHOUT ISSUE. ALSO A 24 CM RESONANCE STENT (RMS-060024-R LOT NUMBER C2134946) WAS PLACED ON THE OTHER SIDE AND WAS PLACED WITHOUT ISSUE. PATIENT/EVENT INFO - NOTES: THE CUSTOMER HAS INDICATED THAT THEY ARE UNABLE TO PROVIDE MUCH MORE INFORMATION. ALL THEY ARE ABLE TO SHARE IS THAT THE WIRE GUIDE WAS NOT INSERTED INTO THE STENT WITH THE RMS 24CM. IT WAS PLACED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526358 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 31 JUL 2024.

  Patient problems: Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 18667395 ↗
• InjuryFeb 8, 2024Migration; Migration

  AS REPORTED TO CUSTOMER RELATIONS VIA CIR COMPLAINT FORM "AS REPORTED TO CUSTOMER RELATIONS VIA CIR COMPLAINT FORM "ON 13JAN2020 THE DEVICE WAS PLACED DUE TO CHRONIC HYDRONEPHROSIS VIA CYSTOSCOPY WITH RETROGRADE PYELOGRAM. PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY. DEVICE WAS REMOVED EMERGENTLY ON (B)(6) 2020 DUE TO COMPLICATION OF STENT DISLODGEMENT AND ENCRUSTATION AND WAS A DEVICE DEFICIENCY. SITE STATED ¿EMERGENT PROCEDURE FOR DISLODGEMENT AND HEAVILY CALCIFIED METAL STENT. THICK, PURULENT EFFLUVIUM RELEASED AFTER NEW STENT PLACED." (B)(4) CAPTURES THE ENCRUSTATION AND THIS COMPLAINT CAPTURES THE STENT DISLODGEMENT PATIENT OUTCOME: THERE IS DATA IS STILL PENDING WITH MULTIPLE QUERIES. SITE STATES THERE WERE ADVERSE EVENTS INVOLVING THE STUDY DEVICE BUT HAS NOT ENTERED THE ADVERSE EVENT DATA. PATIENT/EVENT INFO - NOTES: NO MANUFACTURE ADDITIONAL QUESTIONS WERE ASKED AS THIS IS A CRI PMCF STUDY COMPLAINT. -(B)(4) 09JAN2024.

  Patient problems: Obstruction/Occlusion; Urinary Tract Infection

  MAUDE report 18666717 ↗
• InjuryFeb 6, 2024Complete Blockage; Adverse Event Without Identified Device or Use Problem; Complete Blockage; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS VIA CIR COMPLAINT FORM "ON (B)(6) 2020 THE DEVICE WAS PLACED DUE TO CHRONIC HYDRONEPHROSIS VIA CYSTOSCOPY WITH RETROGRADE PYELOGRAM. PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY. DEVICE WAS REMOVED EMERGENTLY ON (B)(6)2020 DUE TO COMPLICATION OF STENT DISLODGEMENT AND ENCRUSTATION AND WAS A DEVICE DEFICIENCY. SITE STATED ¿EMERGENT PROCEDURE FOR DISLODGEMENT AND HEAVILY CALCIFIED METAL STENT. THICK, PURULENT EFFLUVIUM RELEASED AFTER NEW STENT PLACED." ADDITIONAL FILE CAPTURES THE STENT DISLODGEMENT (B)(4). PATIENT OUTCOME: THERE IS DATA IS STILL PENDING WITH MULTIPLE QUERIES. SITE STATES THERE WERE ADVERSE EVENTS INVOLVING THE STUDY DEVICE BUT HAS NOT ENTERED THE ADVERSE EVENT DATA. PATIENT/EVENT INFO - NOTES: NO MANUFACTURE ADDITIONAL QUESTIONS WERE ASKED AS THIS IS A CRI PMCF STUDY COMPLAINT. -(B)(4).

  Patient problems: Obstruction/Occlusion; Urinary Tract Infection

  MAUDE report 18649071 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER "ON 13JAN2020 THE DEVICE WAS PLACED DUE TO CHRONIC HYDRONEPHROSIS VIA CYSTOSCOPY WITH RETROGRADE PYELOGRAM. PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY. PT PRESENTED TO ED (B)(6) 2020 WITH INFECTION SYMPTOMS WHICH SITE REPORTED AS UTI AND AKI RELATED TO THE DEVICE. DEVICE WAS REMOVED EMERGENTLY ON (B)(6) 2020 DUE TO STENT DISLODGEMENT ((B)(4)) WITH ENCRUSTATION AND WAS A DEVICE DEFICIENCY (ALREADY REPORTED (B)(4)). THICK, PURULENT EFFLUVIUM RELEASED AFTER NEW STENT PLACED. NOTE: STENT LOCATION = RIGHT URETER INDWELL TIME = 105 DAYS

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 18632300 ↗
• InjuryFeb 1, 2024Migration; Migration

  ACCORDING TO THE INITIAL REPORTER "ON 13JAN2020 THE DEVICE WAS PLACED DUE TO CHRONIC HYDRONEPHROSIS VIA CYSTOSCOPY WITH RETROGRADE PYELOGRAM. PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY. DEVICE WAS REMOVED EMERGENTLY ON (B)(6) 2020 DUE TO COMPLICATION OF STENT DISLODGEMENT AND ENCRUSTATION AND WAS A DEVICE DEFICIENCY. SITE STATED ¿EMERGENT PROCEDURE FOR DISLODGEMENT AND HEAVILY CALCIFIED METAL STENT. THICK, PURULENT EFFLUVIUM RELEASED AFTER NEW STENT PLACED." PR (B)(4) CAPTURES THE ENCRUSTATION AND THIS COMPLAINT CAPTURES THE STENT DISLODGEMENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18627059 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER "ON 13JAN2020 THE DEVICE WAS PLACED DUE TO CHRONIC HYDRONEPHROSIS VIA CYSTOSCOPY WITH RETROGRADE PYELOGRAM. PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY. DEVICE WAS REMOVED EMERGENTLY ON (B)(6) 2020 DUE TO COMPLICATION OF STENT DISLODGEMENT AND ENCRUSTATION AND WAS A DEVICE DEFICIENCY. SITE STATED ¿EMERGENT PROCEDURE FOR DISLODGEMENT AND HEAVILY CALCIFIED METAL STENT. THICK, PURULENT EFFLUVIUM RELEASED AFTER NEW STENT PLACED." ADDITIONAL FILE CREATED TO CAPTURE THE STENT DISLODGEMENT. ((B)(4))

  Patient problems: Obstruction/Occlusion

  MAUDE report 18580205 ↗
• MalfunctionDec 16, 2022Fracture; Dent in Material; Fracture; Dent in Material

  PER DM'S EMAIL: (B)(6) THE UROLOGY COORDINATOR DESCRIBES THAT (B)(6) OBSERVED A KINK/UNRAVELING IN THE RMS STENT AFTER DEPLOYMENT DURING THEIR CASE YESTERDAY, 11/14/22. THE STENT WAS SAVED AND GIVEN TO THE PDC MANAGER (B)(6). PHOTOS INCLUDED BUT A BIT BLURRY. NO PATIENT INJURY WAS SUSTAINED DURING THE PROCEDURE. A TRIA STENT FROM BOSTON SCIENTIFIC WAS THEN PLACED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994821 ↗
• InjurySep 23, 2020Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION ON 07-FEB-2022. 1. WHAT IS THE PATIENT¿S ANATOMY TORTUOUS? NO PARTICULAR PROBLEM WITH PATIENT ANATOMY 2. WHAT IS THE SOURCE OF THE EXTRINSIC COMPRESSION? N/A, TUMOR, OTHER. IF OTHER, PLEASE SPECIFY THERE WAS NO COMPRESSION FROM THE CANCER (NO CANCER TREATMENT ONGOING). 3. IF CAUSED BY A TUMOR, WHAT IS THE TUMOR TYPE? THE PATIENT HAS EXPERIENCE IN TREATING CERVICAL CANCER. 4. WHAT IS THE STAGE OF THE TUMOR? REMISSION 5. WAS THE PATIENT USING CALCIUM SUPPLEMENTATION? N/A, YES, NO UNKNOWN. 6. WAS FORCE REQUIRED TO REMOVE THE STENT? N/A, YES, NO UNKNOWN . 7. WAS ENCRUSTATION EVIDENT ON THE STENT? N/A, YES, NO UNKNOWN.

  Patient problems: Fistula; Hematuria; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10574513 ↗
• InjurySep 9, 2020Migration; Migration

  COMPLAINT RECEIVED FROM DM VIA E-MAIL ON 12AUG2020--DID 13AUG2020. AS REPORTED TO CUSTOMER RELATIONS: "PLEASE SEE INFORMATION REGARDING A COMPLAINT MADE BY ACCOUNT (B)(6). CUSTOMER¿S ACCOUNT NAME AND NUMBER. (B)(6). CONTACT PERSON¿S NAME, TELEPHONE NUMBER AND TITLE. DR. (B)(6) PATIENT INFO (E.G. PT ID, AGE, GENDER, WT.). N/A. PROCEDURE PERFORMED. BILATERAL RESONANCE METALLIC STENT PLACEMENT DATE OF PLACEMENT (DOP). (B)(6) 2020. DATE OF EVENT (DOE). (B)(6) 2020. CATALOG NUMBER OF PRODUCT (RPN). RMS-060022-R. OTHER PRODUCTS INVOLVED. NO OTHER PRODUCTS INVOLVED. LOT NUMBER(S). C1713983 (X2). CAN USED AND/OR UNUSED PRODUCT BE RETURNED? IF SO, WHEN? NO. HAS PRODUCT BEEN CONTAMINATED WITH KNOWN CONTAGIONS? NO. WHAT MEDICATIONS WERE BEING ADMINISTERED? N/A. WHAT IS THE PATIENT¿S CURRENT CONDITIONA. STABLE". ADDITIONAL INFORMATION PROVIDED BY DM ON 17AUG2020: " WHAT WAS THE PROBLEM WITH THE DEVICES? THE DEVICE FAILED TO DRAIN THE KIDNEY THAT WAS PLACED IN THE RIGHT URETER ((B)(4)) AND THE STENT IN THE LEFT URETER MIGRATED DOWN THE URETER BECAUSE OF OVER DILATION ((B)(4)). CAN YOU CLARIFY THE DATES AND PROCEDURE LISTED IN YOUR E-MAIL? IT INDICATES A PLACEMENT DATE OF (B)(6) 2020, AN EVENT D

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10511846 ↗
• InjurySep 9, 2020Complete Blockage; Complete Blockage

  COMPLAINT RECEIVED FROM (B)(6) VIA E-MAIL ON 12AUG2020 (B)(6) 13AUG2020. AS REPORTED TO CUSTOMER RELATIONS: "PLEASE SEE INFORMATION REGARDING A COMPLAINT MADE BY ACCOUNT (B)(4) ((B)(6) HOSPITAL). CUSTOMER¿S ACCOUNT NAME AND NUMBER. (B)(6) HOSPITAL ((B)(4)) CONTACT PERSON¿S NAME, TELEPHONE NUMBER AND TITLE. DR. (B)(6) (UROLOGIST) (B)(6) PATIENT INFO (E.G. PT ID, AGE, GENDER, WT.). A. N/A PROCEDURE PERFORMED. BILATERAL RESONANCE METALLIC STENT PLACEMENT. DATE OF PLACEMENT (DOP). (B)(6) 2020. DATE OF EVENT (DOE). (B)(6) 2020. CATALOG NUMBER OF PRODUCT (RPN). RMS-060022-R. OTHER PRODUCTS INVOLVED. NO OTHER PRODUCTS INVOLVED. LOT NUMBER(S). C1713983 (X2). CAN USED AND/OR UNUSED PRODUCT BE RETURNED? IF SO, WHEN? NO. HAS PRODUCT BEEN CONTAMINATED WITH KNOWN CONTAGIONS? NO. WHAT MEDICATIONS WERE BEING ADMINISTERED? N/A. WHAT IS THE PATIENT¿S CURRENT CONDITION. STABLE." ADDITIONAL INFORMATION PROVIDED BY DM ON 17AUG2020: "WHAT WAS THE PROBLEM WITH THE DEVICES? THE DEVICE FAILED TO DRAIN THE KIDNEY THAT WAS PLACED IN THE RIGHT URETER (THIS PR) AND THE STENT IN THE LEFT URETER MIGRATED DOWN THE URETER BECAUSE OF OVER DILATION (COOK (B)(4) REF # (B)(4). CAN YOU CLARIFY THE DATES AND PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10511844 ↗
• InjurySep 9, 2020Migration; Migration

  ACCORDING TO THE INITIAL REPORTER THE DEVICE FAILED TO DRAIN THE KIDNEY THAT WAS PLACED IN THE RIGHT URETER (SEPARATE COMPLAINT) AND THE STENT IN THE LEFT URETER MIGRATED DOWN THE URETER BECAUSE OF OVER DILATION (SUBJECT OF THIS REPORT). BOTH STENTS WERE INITIALLY PLACED ON (B)(6) 2020 AND THEN REMOVED ON (B)(6) 2020 DUE TO A PERCEIVED FAILURE. THE PROCEDURE FOLLOWING THE INCIDENT WAS A SIMPLE STENT EXCHANGE OF BOTH RMS STENTS. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Code Available

  MAUDE report 10507153 ↗
• InjurySep 2, 2020Failure to Discharge; Failure to Discharge

  ACCORDING TO THE INITIAL REPORTER THE DEVICE FAILED TO DRAIN THE KIDNEY THAT WAS PLACED IN THE RIGHT URETER (SUBJECT OF THIS REPORT) AND THE STENT IN THE LEFT URETER MIGRATED DOWN THE URETER BECAUSE OF OVER DILATION (SEPARATE COMPLAINT). BOTH STENTS WERE INITIALLY PLACED ON (B)(6) 2020 AND THEN REMOVED ON (B)(6) 2020 DUE TO A PERCEIVED FAILURE. THE PROCEDURE FOLLOWING THE INCIDENT WAS A SIMPLE STENT EXCHANGE OF BOTH RMS STENTS. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Code Available

  MAUDE report 10484654 ↗
• MalfunctionMay 7, 2020Inadequacy of Device Shape and/or Size; Device Damaged Prior to Use; Inadequacy of Device Shape and/or Size; Device Damaged Prior to Use

  COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON (B)(6) 2020. ONE PIGTAIL WAS LOOSER AND APPEARS LARGER THAN OTHER PIGTAIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10034166 ↗
• MalfunctionFeb 27, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  FAULT WITH THE EQUIPMENT DURING THE PROCEDURE. WHEN THE STENT WAS BEING PREPPED BY THE SCRUB NURSE, THERE WAS NO INJURY TO THE PATIENT AND ANOTHER STENT WAS USED ON CC FORM. IT WAS NOTICED THAT THERE WAS A FAULT WITH THE EQUIPMENT DURING THE PROCEDURE WHEN THE STENT WAS BEING PREPPED BY THE SCRUB NURSE, THE GREEN PUSHER WAS FAULTY AS THE BLACK MARKER WAS RAISED THEREFORE THE STENT COULD NOT BE DEPLOYED. THERE WAS NO INJURY TO THE PATIENT AND ANOTHER STENT WAS USED ON THE PATIENT SUCCESSFULLY. FDA MDR REPORTING REQUIRED - EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿SHEATH BREAKAGE (INTRODUCTION SYSTEM)'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8373253 ↗
• InjuryNov 22, 2018Break; Break

  RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES AFTER 12 MONTHS OF PLACEMENT. ONE STENT COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE PATIENT. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. UPDATED ON (B)(6) 2018, ON (B)(6) 2017 (EXACT DATE UNKNOWN): RMS-060022-R/ LOT# C1296687 (COMPLAINT DEVICE) AND RMS-060022-R/ LOT# C1307377 WERE PLACED IN THE RIGHT AND LEFT SIDES RESPECTIVELY. THERE HAD BEEN NO PROBLEM OBSERVED IN THE RENAL FUNCTION AND DEVICES PERFORMANCE OF DRAINAGE DURING PLACEMENT. ON (B)(6) 2018: RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES. ONE STENT (C1307377) COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT (C1296687) AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8098868 ↗
• InjuryOct 31, 2018Break; Break

  PER THE SUS REPORT, "WHILE ATTEMPTING TO PLACE A URETERAL STENT A PIECE OF THE PUSH SHEATHING BROKE OFF FOR UNKNOWN REASONS. THE BROKEN PIECE WAS CLEARLY VISIBLE UNDER FLUOROSCOPY. A URETEROSCOPY WAS PERFORMED AND THE FOREIGN BODY WAS REMOVED IN ITS ENTIRETY. FLUOROSCOPY AND DIRECT VISION WERE AGAIN UTILIZED TO VERIFY NO REMAINING PIECES WERE LEFT. THE STENT WAS PLACED AND THE CASE FINISHED WITHOUT FURTHER INCIDENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8022863 ↗
• InjuryOct 11, 2018Break; Break

  AS REPORTED TO CUSTOMER RELATIONS, "A PIECE OF STENT SHEATHING BROKE OFF DURING A STENT REPLACEMENT PROCEDURE. THE PIECE WAS COMPLETELY REMOVED- NO INJURY." INFO PROVIDED AS WELL ON CUSTOMER'S EMAIL TRAIN: ONE OF OUR UROLOGISTS HAD A PIECE OF THE SHEATHING BREAK OFF DURING A STENT PLACEMENT IN THE OR. THE FOREIGN BODY WAS REMOVED IN ITS ENTIRETY. THE PATIENT IS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7955552 ↗
• MalfunctionMay 3, 2017Kinked; Failure to Advance; Kinked; Failure to Advance

  ON INSERTING THE RESONANCE STENT THROUGH THE CLEAR SHEATH THE STENT, ONCE FULLY INSIDE THE SHEATH, WOULD NOT ADVANCE. THE SURGEON WAS USING THE CATHETER AS A PUSHER AND COULD NOT ADVANCE THE STENT. HE THEN TRIED A 5FR OPEN END URETERAL CATHETER BUT COULD NOT ADVANCE IT FURTHER. IT WAS THEN DISCOVERED THAT THE SHEATH HAD KINKED AND THE BEND IN THE PLASTIC WAS PREVENTING THE STENT FROM ADVANCING. AFTER STRAIGHTENING THE KINK, AND ATTEMPTING TO ADVANCE THE STENT, THE STENT UNDER I.I APPEARED TO DIVERT IN A DIFFERENT DIRECTION FROM THE RADIO OPAQUE MARKER ON THE END OF THE SHEATH. DUE TO CONCERNS OVER THE INTEGRITY OF THE KINKED SHEATH, A SECOND RESONANCE STENT SET WAS OPENED. THE KINKED SHEATH AND STENT WERE REMOVED AND THE SURGEON STARTED AGAIN USING THE NEW SHEATH. THE RESONANCE STENT WAS THEN ADVANCED AS PER NORMAL. THE SURGEON AND CN (NURSE) ARE NOW UNDER THE IMPRESSION THAT THE PLASTIC OF THE SHEATH WAS WEAKER THAN NORMAL, CAUSING THE KINK THAT THEN REQUIRED USE OF ANOTHER SHEATH. THE SHEATH WAS NOT RECOVERED AT THE END OF THE CASE AS THE PATIENT WAS VRE-POSITIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6539832 ↗
• InjuryMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE; ¿AS REPORTED TO CUSTOMER RELATIONS: "DURING A LEFT URETERAL EXCHANGE PROCEDURE THE DISTRICT MANAGER MISSPOKE INSTRUCTIONS OF THE PRODUCT. THE PHYSICIAN WAS PUTTING THE STENT IN THE LEFT URETER, WHEN TELLING TO PULL THE GREEN SYSTEM DOWN IT WAS STATED TO THE PHYSICIAN TO PULL THE GREEN AND CLEAR SYSTEM DOWN. SHE REALIZED SHE STATED THAT INCORRECTLY AND STOPPED THE PHYSICIAN. SHE EXPLAINED THAT SHE SHOULD HAVE STATED TO PULL ONLY THE GREEN TO THE PHYSICIAN. AS SHE HAD MISSPOKEN SHE THEN STATED TO REMOVE THE CLEAR ONE FROM THE ARBERATOR. THE PHYSICIAN LOST ACCESS. REGAINING ACCESS WAS ATTEMPTED WITH A HYBRID WIRE BUT UNSUCCESSFUL. ALSO TRIED WITH A HYDROPHILIC WIRE AND WAS UNSUCCESSFUL. THE STENT DID FALL OUT AND WAS RETRIEVED FROM THE PATIENT WITH GRASPERS. PROCEDURE WAS STOPPED AND THE PATIENT WAS SENT TO THE IR DEPARTMENT THE NEXT DAY. DISTRICT MANAGER WAS PRESENT FOR THIS SECOND PROCEDURE AND CONFIRMED ALL WENT AS INTENDED AND WELL.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 6539746 ↗
• MalfunctionFeb 27, 2017Difficult to Remove; Difficult to Remove

  THIS REPORT- AROUND ONE MONTH AGO, THEY TRIED TO REMOVE THE STENT UNDER LOCAL ANESTHESIA AND WERE UNABLE TO DO SO. THEY COULD NOT GET IT TO COME OUT. MDR REF # 3001845648-2017-00067 - A SECOND UNSUCCESSFUL RETRIEVAL ATTEMPT WAS PERFORMED WITHIN THE LAST MONTH. THEY TRIED TO REMOVE IT UNDER GENERAL ANESTHESIA BUT WERE UNABLE TO DO SO. MDR REF # 3001845648-2017-00064 - A THIRD PLANNED RETRIEVAL ATTEMPT WITH LITHOTRIPSY WAS PERFORMED ON (B)(6) 2017. WHILE ATTEMPTING TO REMOVE THE STENT, THE STENT UNCOILED AND BECAME STUCK IN THE PATIENT'S BLADDER. THEY CUT THE UNCOILED PORTION OF THE STENT AND REMOVED THE UNCOILED SECTION FROM THE BLADDER. THE REST OF THE STENT IS STILL IN THE PATIENT. THEY TRIED TO GO UP WITH A URETEROSCOPE, BUT COULD NOT GET THE URETEROSCOPE UP TO THE PELVIS OF THE KIDNEY. THEY COULD NOT GET UP TO THE STONE THAT WAS HOLDING THE STENT IN PLACE. THEY PUT A WIRE UP THROUGH THE URETEROSCOPE AND PLACED A POLYMER STENT. THE POLYMER STENT WAS PLACED IN ORDER TO DILATE THE URETER IN HOPE THAT THE URETER WILL DILATE ENOUGH TO REMOVE THE REMAINING PART OF THE RESONANCE STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6360325 ↗
• InjuryFeb 27, 2017Difficult to Remove; Difficult to Remove

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION FINDINGS. MDR REF # 3001845648-2017-00066 - AROUND ONE MONTH AGO, THEY TRIED TO REMOVE THE STENT UNDER LOCAL ANESTHESIA AND WERE UNABLE TO DO SO. THEY COULD NOT GET IT TO COME OUT. THIS REPORT (MDR REF # 3001845648-2017-00067) - A SECOND UNSUCCESSFUL RETRIEVAL ATTEMPT WAS PERFORMED WITHIN THE LAST MONTH. THEY TRIED TO REMOVE IT UNDER GENERAL ANESTHESIA BUT WERE UNABLE TO DO SO. MDR REF # 3001845648-2017-00064 - A THIRD PLANNED RETRIEVAL ATTEMPT WITH LITHOTRIPSY WAS PERFORMED ON (B)(6) 2017. WHILE ATTEMPTING TO REMOVE THE STENT, THE STENT UNCOILED AND BECAME STUCK IN THE PATIENT'S BLADDER. THEY CUT THE UNCOILED PORTION OF THE STENT AND REMOVED THE UNCOILED SECTION FROM THE BLADDER. THE REST OF THE STENT IS STILL IN THE PATIENT. THEY TRIED TO GO UP WITH A URETEROSCOPE, BUT COULD NOT GET THE URETEROSCOPE UP TO THE PELVIS OF THE KIDNEY. THEY COULD NOT GET UP TO THE STONE THAT WAS HOLDING THE STENT IN PLACE. THEY PUT A WIRE UP THROUGH THE URETEROSCOPE AND PLACED A POLYMER STENT. THE POLYMER STENT WAS PLACED IN ORDER TO DILATE THE URETER IN HOPE THAT THE URETER WILL DILATE ENOUGH TO REMOVE THE REMAINING PART OF THE RES

  Patient problems: Foreign Body In Patient; Pain; Unspecified Infection

  MAUDE report 6360324 ↗
• InjuryFeb 27, 2017Difficult to Remove; Uncoiled; Difficult to Remove; Uncoiled

  MDR REF # 3001845648-2017-00066 - AROUND ONE MONTH AGO, THEY TRIED TO REMOVE THE STENT UNDER LOCAL ANESTHESIA AND WERE UNABLE TO DO SO. THEY COULD NOT GET IT TO COME OUT. MDR REF # 3001845648-2017-00067 - A SECOND UNSUCCESSFUL RETRIEVAL ATTEMPT WAS PERFORMED WITHIN THE LAST MONTH. THEY TRIED TO REMOVE IT UNDER GENERAL ANESTHESIA BUT WERE UNABLE TO DO SO. THIS REPORT - A THIRD PLANNED RETRIEVAL ATTEMPT WITH LITHOTRIPSY WAS PERFORMED ON (B)(6) 2017. WHILE ATTEMPTING TO REMOVE THE STENT, THE STENT UNCOILED AND BECAME STUCK IN THE PATIENT'S BLADDER. THEY CUT THE UNCOILED PORTION OF THE STENT AND REMOVED THE UNCOILED SECTION FROM THE BLADDER. THE REST OF THE STENT IS STILL IN THE PATIENT. THEY TRIED TO GO UP WITH A URETEROSCOPE, BUT COULD NOT GET THE URETEROSCOPE UP TO THE PELVIS OF THE KIDNEY. THEY COULD NOT GET UP TO THE STONE THAT WAS HOLDING THE STENT IN PLACE. THEY PUT A WIRE UP THROUGH THE URETEROSCOPE AND PLACED A POLYMER STENT. THE POLYMER STENT WAS PLACED IN ORDER TO DILATE THE URETER IN HOPE THAT THE URETER WILL DILATE ENOUGH TO REMOVE THE REMAINING PART OF THE RESONANCE STENT.

  Patient problems: Foreign Body In Patient; Pain; Unspecified Infection

  MAUDE report 6360204 ↗
• InjuryFeb 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  STENT WAS PLACED ON (B)(6) 2016 AND DURING A RECENT CHECK UP, THE STENT WAS NOTED TO HAVE MOSTLY DESCENDED INTO PATIENT'S BLADDER. UPDATE AS OF 14FEB2017: DUE TO HYDRONEPHROSIS, THE URETER WILL NOT HOLD STENT IN PLACE. IT IS UNKNOWN IF THE PRODUCT HAS BEEN REMOVED FORM THE PATIENT. UPDATE AS OF 20FEB2017: DM CALLED IN STATING THE STENT WAS REMOVED (AND DISCARDED) AND WAS REPLACED WITH A BOSTON SCIENTIFIC STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6348712 ↗