MAHURKAR 8813793013Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521004832), received between Jun 22, 2017 and Apr 25, 2025 — classified as 1 death, 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, THE GUIDE WIRE FROM THE KIT BECAME STUCK INSIDE THE NEEDLE AFTER IT WAS INSERTED INTO IT; IT COULD NO LONGER BE INSERTED OR REMOVED FROM THE NEEDLE. THIS CAUSED THE GUIDE WIRE TO "FRAY" AS A WHOLE, RESULTING IN THE LOSS OF THE PUNCTURE AND REQUIRING THE DISPENSATION OF ANOTHER PUNCTURE KIT (REPLACED). THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21913542 ↗
• MalfunctionFeb 26, 2025Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS DELIVERED TO THE HOSPITAL, THE WAREHOUSE COORDINATOR DECIDED TO SEND A 25-PIECE SAMPLE TO THE COMPETENT AUTHORITY TO ANALYZE THE PRODUCTS, AND IT WAS FOUND THAT THE CATHETER HAD A DEFORMATION OF THE TIP (OBLIQUE TIP). THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CATHETER'S TIP WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21473193 ↗
• MalfunctionNov 15, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE HCP (HEALTH CARE PROFESSIONAL) INTRODUCED THE GUIDEWIRE, AND WHEN THE HCP TRIED TO RETIRE IT, THE GUIDEWIRE FRAYED. THE GUIDE WIRE WAS STUCK AND REMOVED AT THE SAME TIME AS THE NEEDLE WITH WHICH THE GUIDE WIRE WAS PUNCTURED. THE INCIDENT OCCURRED TWICE WITH THE SAME PATIENT. NO TOOLS WERE USED TO REMOVE THE GUIDE WIRE. FLUSHING WAS DONE PRIOR TO USE. NO RESISTANCE WHEN INSERTING THE GUIDEWIRE. NO EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE GUIDEWIRE. THE GUIDE WIRE DID NOT BREAK. THE GUIDE USED WAS THE ONE INCLUDED IN THE KIT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. A CLEANING AGENT WAS USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER KIT WAS REPLACED WITH THE SAME BRAND TO ADDRESS THE ISSUE. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO BLOOD LOSS. A BLOOD TRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692738 ↗
• MalfunctionNov 14, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE HCP (HEALTH CARE PROFESSIONAL) INTRODUCED THE GUIDEWIRE, AND WHEN THE HCP TRIED TO RETIRE IT, THE GUIDEWIRE FRAYED. THE GUIDE WIRE WAS STUCK AND REMOVED AT THE SAME TIME AS THE NEEDLE WITH WHICH THE GUIDE WIRE WAS PUNCTURED. THE INCIDENT OCCURRED TWICE WITH THE SAME PATIENT. NO TOOLS WERE USED TO REMOVE THE GUIDE WIRE. FLUSHING WAS DONE PRIOR TO USE. NO RESISTANCE WHEN INSERTING THE GUIDEWIRE. NO EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE GUIDEWIRE. THE GUIDE WIRE DID NOT BREAK. THE GUIDE USED WAS THE ONE INCLUDED IN THE KIT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. A CLEANING AGENT WAS USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER KIT WAS REPLACED WITH THE SAME BRAND TO ADDRESS THE ISSUE. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO BLOOD LOSS. A BLOOD TRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684135 ↗
• MalfunctionJul 24, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, A PATIENT WITH END-STAGE RENAL DISEASE DUE TO PROBABLE IGA NEPHROPATHY STARTED HEMODIALYSIS IN (B)(6) 2022. EXPLANTATION OF AN EXHAUSTED BRACHIOAXILLARY GRAFT OCCURRED ON (B)(6) 2024, NECESSITATING A TUNNELED LINE TO CONTINUE DIALYSIS. IT WAS STATED THAT DIALYSIS LINE WAS REPLACED DUE TO NON-FUNCTION. STANDARD CLEANING OF DIALYSIS CATHETERS IN THE UNIT WAS DONE WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19817314 ↗
• MalfunctionJan 23, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, THE TWO CATHETER KITS' GUIDE WIRE HAD DISSOLVED, WHICH MEANT IT LOST ITS RIGIDITY AND BECAME A SPRING. THE GUIDE WIRE WAS STUCK. NO TOOLS WERE USED TO REMOVE THE GUIDEWIRE. NO EXCESSIVE FORCE WAS APPLIED TO THE PRODUCT. THE GUIDEWIRE DID NOT BREAK INTO TWO PIECES OR MULTIPLE PIECES. THE GUIDE WIRE USED WAS INCLUDED IN THE KIT. THE DIMENSIONS OF THE CATHETER AND GUIDEWIRE CORRESPONDED TO WHAT WAS INDICATED ON THE LABEL. THERE WERE NO SIZING ISSUES NOTED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO RINSING DONE BEFORE USE. NO OTHER PRODUCTS WERE BEING USED WITH THE DEVICE. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. TEGO WAS NOT USED. THE INSERTION SITE OR SKIN WAS TREATED OR CLEANSED WITH CHLORHEXIDINE DEGERMANTE AND LATER WITH CHLOREX ALCOHOLIC BEFORE PLACING THE PRODUCT, WHICH WAS ACCORDING TO THE INFECTION PREVENTION BUNDLE. THERE WAS NO REPORT OF OCCLUSION. NO CATHETERS WERE REPAIRED OR REUSED. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE SIMULTANEOUSLY WITH THE CATHETER. IT WAS MANUALLY REMOVED BY HAND. THEY OPENED ANOTHER KIT AND THE PROCEDURE WAS COMPLETED AFTER RESOLVING THE PROBLEM. THERE WAS NO BLOOD LOSS. A BL OOD TRANSFUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563616 ↗
• MalfunctionJan 23, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, THE TWO CATHETER KITS' GUIDE WIRE HAD DISSOLVED, WHICH MEANT IT LOST ITS RIGIDITY AND BECAME A SPRING. THE GUIDE WIRE WAS STUCK. NO TOOLS WERE USED TO REMOVE THE GUIDEWIRE. NO EXCESSIVE FORCE WAS APPLIED TO THE PRODUCT. THE GUIDEWIRE DID NOT BREAK INTO TWO PIECES OR MULTIPLE PIECES. THE GUIDE WIRE USED WAS INCLUDED IN THE KIT. THE DIMENSIONS OF THE CATHETER AND GUIDEWIRE CORRESPONDED TO WHAT WAS INDICATED ON THE LABEL. THERE WERE NO SIZING ISSUES NOTED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO RINSING DONE BEFORE USE. NO OTHER PRODUCTS WERE BEING USED WITH THE DEVICE. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. TEGO WAS NOT USED. THE INSERTION SITE OR SKIN WAS TREATED OR CLEANSED WITH CHLORHEXIDINE DEGERMANTE AND LATER WITH CHLOREX ALCOHOLIC BEFORE PLACING THE PRODUCT, WHICH WAS ACCORDING TO THE INFECTION PREVENTION BUNDLE. THERE WAS NO REPORT OF OCCLUSION. NO CATHETERS WERE REPAIRED OR REUSED. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE SIMULTANEOUSLY WITH THE CATHETER. IT WAS MANUALLY REMOVED BY HAND. THEY OPENED ANOTHER KIT AND THE PROCEDURE WAS COMPLETED AFTER RESOLVING THE PROBLEM. THERE WAS NO BLOOD LOSS. A BL OOD TRANSFUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563585 ↗
• MalfunctionDec 27, 2023Misassembled; Product Quality Problem; Unraveled Material; Misassembled; Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, THERE WAS DEFORMITY OF THE GUIDE WIRE DURING REMOVAL AND RESISTANCE TO REMOVING THE GUIDE WIRE. TWO KITS WERE OPENED, AS ONE OF THEM WAS MISSING THE DILATOR. IT WAS ALSO ON THE REPORT THAT THE GUIDE WIRE WAS COILED (BASED ON THE PICTURE). THERE WAS NO LEAK. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406764 ↗
• MalfunctionDec 27, 2023Product Quality Problem; Difficult to Remove; Unraveled Material; Product Quality Problem; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, DIALYSIS WAS INDICATED FOR THE PATIENT. IN THAT WAY, PROGRESS WAS MADE WITH THE IMPLEMENTATION OF CDL (CATHETER DUEL LUMEN). THE PATIENT HAD A CVC (CENTRAL VENOUS CATHETER) IN THE INTERNAL JUGULAR VEIN; FOR THIS REASON, THE INTERNAL JUGULAR VEIN WAS CHOSEN, AND A SUCCESSFUL PUNCTURE WAS GUIDED BY USG (ULTRASOUND SONOGRAPHY) WITH GOOD PROGRESSION OF THE GUIDE WIRE. AFTER INSERTION OF THE CATHETER, THE GUIDEWIRE "OPENED," POSING A RISK TO THE PATIENT. THE GUIDE WIRE WAS SHOWING DEFECTS DURING REMOVAL AND WAS BENDING INSIDE THE CATHETER. THERE WAS RESISTANCE AND DEFORMATION OF THE GUIDE WIRE. IT WAS NECESSARY TO REMOVE THE ENTIRE CATHETER WITH THE GUIDEWIRE. A NEW PUNCTURE ATTEMPT WAS MADE, AS SUCCESSFULLY AS THE FIRST, WITH THE SAME FAILURE IN REMOVING THE GUIDE WIRE, WHICH "OPENED LIKE A SPRING" AND "DISSOLVED," ONCE AGAIN LEADING TO THE REMOVAL OF THE ENTIRE CDL CONTAINING THE GUIDE WIRE STUCK INSIDE. OPENING WAS ONLY SUCCESSFUL ON THE 3RD ATTEMPT AND WITH THE 3RD NEW KIT. THE IMPACT ON THE PATIENT WAS THE RISK OF ENDOVASCULAR INJURY AND INFECTION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406517 ↗
• MalfunctionDec 27, 2023Misassembled; Product Quality Problem; Difficult to Remove; Unraveled Material; Misassembled; Product Quality Problem; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, THERE WAS DEFORMITY OF THE GUIDE WIRE DURING REMOVAL AND RESISTANCE TO REMOVING THE GUIDE WIRE. TWO KITS WERE OPENED, AS ONE OF THEM WAS MISSING THE DILATOR. IT WAS ALSO ON THE REPORT THAT THE GUIDE WIRE WAS COILED (BASED ON THE PICTURE). THERE WAS NO LEAK. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18404936 ↗
• MalfunctionDec 27, 2023Product Quality Problem; Difficult to Remove; Unraveled Material; Product Quality Problem; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, A PUNCTURE ATTEMPT WAS SUCCESSFUL; HOWEVER, AFTER INSERTION OF THE CATHETER, THERE WAS FAILURE IN REMOVING THE GUIDE WIRE, WHICH "OPENED LIKE A SPRING" AND "DISSOLVED", LEADING TO THE REMOVAL OF THE ENTIRE CDL (CATHETER DUEL LUMEN) CONTAINING THE GUIDE WIRE STUCK INSIDE. THE GUIDE WIRE WAS SHOWING DEFECTS DURING REMOVAL AND WAS BENDING INSIDE THE CATHETER. THERE WAS RESISTANCE AND DEFORMATION OF THE GUIDE WIRE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18404702 ↗
• MalfunctionDec 27, 2023Product Quality Problem; Difficult to Remove; Unraveled Material; Product Quality Problem; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, DIALYSIS WAS INDICATED FOR THE PATIENT. IN THAT WAY, PROGRESS WAS MADE WITH THE IMPLEMENTATION OF CDL (CATHETER DUEL LUMEN). THE PATIENT HAD A CVC (CENTRAL VENOUS CATHETER) IN THE INTERNAL JUGULAR VEIN; FOR THIS REASON, THE INTERNAL JUGULAR VEIN WAS CHOSEN, AND A SUCCESSFUL PUNCTURE WAS GUIDED BY USG (ULTRASOUND SONOGRAPHY) WITH GOOD PROGRESSION OF THE GUIDE WIRE. AFTER INSERTION OF THE CATHETER, THE GUIDEWIRE "OPENED," POSING A RISK TO THE PATIENT. THE GUIDE WIRE WAS SHOWING DEFECTS DURING REMOVAL AND WAS BENDING INSIDE THE CATHETER. THERE WAS RESISTANCE AND DEFORMATION OF THE GUIDE WIRE. IT WAS NECESSARY TO REMOVE THE ENTIRE CATHETER WITH THE GUIDEWIRE. A NEW PUNCTURE ATTEMPT WAS MADE, AS SUCCESSFULLY AS THE FIRST, WITH THE SAME FAILURE IN REMOVING THE GUIDE WIRE, WHICH "OPENED LIKE A SPRING" AND "DISSOLVED", ONCE AGAIN LEADING TO THE REMOVAL OF THE ENTIRE CDL CONTAINING THE GUIDE WIRE STUCK INSIDE. OPENING WAS ONLY SUCCESSFUL ON THE 3RD ATTEMPT AND WITH THE 3RD NEW KIT. THE IMPACT ON THE PATIENT WAS THE RISK OF ENDOVASCULAR INJURY AND INFECTION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18404607 ↗
• MalfunctionJan 18, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN INSERTING GUIDE WIRE INTO THE CATHETER AT THE CATHETER TIP, IT GOT STUCK AND DID NOT GO THROUGH EITHER END. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THEY ONLY OPENED TWO CATHETERS AND THE HEALTH PROFESSIONAL DECIDED NOT TO USE THE CATHETERS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195631 ↗
• MalfunctionDec 19, 2022Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, A CATHETER WAS IMPLANTED IN THE PATIENT, IT WAS OBSERVED THAT THE PRODUCT HAD LIQUID/FLUID LEVEL LEAKAGE AT THE CATHETER BASE LEVEL. THERE WAS A PERFORATION (A SMALL POINT) IN THE CATHETER WHERE THE LEAK WAS LOCATED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED. THE CATHETER WAS REPAIRED. DUE TO THE ISSUE THE CATHETER WAS REPLACED WITH A 19.5 CM CATHETER (WITH NO COMPLICATIONS). THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009279 ↗
• InjuryDec 12, 2022Break; Break

  ACCORDING TO THE REPORTER, 10 SECONDS AFTER THE TREATMENT WAS STARTED, THE CATHETER HAD A LEAK AT THE BIFURCATE (OUTSIDE OR EXTERNAL OF THE CATHETER'S BIFURCATE). THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. PRIMING WAS PERFORMED WITH NO PROBLEM RESULT. THE CATHETER WAS NOT REPAIRED, ASEPSIS WITH ISODINE SOLUTION WAS USED AS THE CLEANING AGENT ON THE DEVICE, THERE WAS NO LUER ADAPTER ISSUE, AND ISODINE SOLUTION WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO MACHINE ALARM ACTIVATED, BLOOD TEST STRIPS WERE NOT USED, THERE WAS NO DAMAGE OBSERVED TO THE DIALYZER AND THERE WAS NO DAMAGE OBSERVED TO THE PRIMARY OR SECONDARY PACKAGING OF THE DIALYZER. THE PATIENT DID NOT HAVE ANY REACTION AND THE PATIENT WAS TREATED TWO TIMES PER WEEKS FOR 10 MONTHS WITH HEMODIALYSIS THERAPY. THE DIALYSATE FLOW RATE (DFR) WAS 800 AND BLOOD FLOW RATE (BFR) WAS 200. THE EVENT HAD CAUSED OR PROLONG THE PATIENT'S HOSPITALIZATION, MICROPORE WAS USED FOR THE WOUND DRESSING, THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AG

  Patient problems: Insufficient Information

  MAUDE report 15958612 ↗
• MalfunctionMar 24, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN THE NEPHROLOGIST WAS INSERTING THE LINE AS PER THE USUAL PROCEDURE, IT WAS UNABLE TO THREAD THE GUIDEWIRE THROUGH THE 11.5 F 19.5 CM LINE. IT WAS ALSO MENTIONED THAT IT APPEARED TO HAVE A COMPLETE OCCLUSION AT THE VENOUS PORT JUST PASSED THE TIP OF THE CATHETER. THEY STOPPED USING THE LINE AND A NEW ONE WAS USED. THEY EXAMINED THE CATHETER AND DEFINITELY WOULD NOT PASS THE GUIDEWIRE BEYOND APPROXIMATELY 1.5 CM (CENTIMETER) PAST THE TIP. IT COULD PASS THE GUIDEWIRE THROUGH THE VENOUS PORT, DOWN TO ALMOST THE TIP AND THEN IT WAS OCCLUDED AGAIN. THE CATHETER WAS FLUSHED WITH 10 ML (MILLILITER) OF NORMAL SALINE AND THE FLUID EXITED AT THE VENOUS SIDE OPENING BEFORE THE TIP. THE PROCEDURE WAS COMPLETED AFTER THE DEVICE WAS REPLACED, THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO LEAK, THERE WAS NO LUER ADAPTER ISSUE AND PROCEDURE WAS ABORTED BEFORE TEGO WAS UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO A NY OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED, AND THE OCCLUSION WAS NOT DUE TO THROMBOSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891043 ↗
• DeathMar 3, 2022Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE GUIDE WIRE THAT CAME WITH THE CATHETER WAS DEFECTIVE (IT WAS OBSERVED TO BE CROOKED) MAKING IT DIFFICULT TO USE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. IT WAS IMPOSSIBLE TO USE AND THEY REPLACED IT WITH ANOTHER CATHETER. THERE WAS NO BLEEDING AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INCREASE IN SURGICAL TIME AND THE EVENT DID NOT PROLONG HOSPITALIZATION. THE PATIENT DIED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 13660925 ↗
• MalfunctionAug 10, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER HAD A FISSURE OR CRACK IN THE ARTERIAL ROUTE/PATHWAY COMPROMISING ITS FUNCTIONING. THE USE OF THE PRODUCT FOLLOWED THE MANUFACTURER'S INSTRUCTIONS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12302301 ↗
• InjuryJun 30, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING THE REMOVAL OF THE GUIDE WIRE AFTER PASSAGE OF THE CATHETER, THE GUIDE WIRE BROKE INTO TWO (GUIDE WIRE WAS UNWOUND). THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. ALCOHOLIC CHLORHEXHYDRIN DEGERANT WAS USED AS THE CLEANING AGENT ON THE DEVICE AND WAS ALSO USED AT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO EXCESSIVE FORCE USED TO PULL/REMOVE THE PRODUCT AND THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE USE. BEFORE THE BREAKAGE, THERE WERE NO ABNORMAL CONDITIONS NOTED. FLUSHING WAS DONE WHICH HAD A NORMAL RESULT. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AND NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THERE WERE NO TOOLS USED WHEN THEY TRIED TO REMOVE THE GUIDE WIRE. AN X-RAY MACHINE WAS USED TO CHECK FOR RETAINED PARTS. ALL PARTS WERE RECOVERED. THE PRODUCT HAD TO BE REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND NO INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. IT DID NOT LEAD TO OR PROLONGED THE PATIENT'S HOSPITALIZATION.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12089926 ↗
• MalfunctionJan 4, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CATHETER THAT WAS NEWLY INSERTED HAD A FRACTURED/CRACKED AT THE LUER ADAPTER (DISTAL PORT SITE CONNECTION). THE CATHETER WAS NOT REPAIRED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11108982 ↗
• MalfunctionSep 17, 2020Material Frayed; Difficult to Remove; Material Twisted/Bent; Material Frayed; Difficult to Remove; Material Twisted/Bent

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PATIENT ENTERED THE OPERATING ROOM UNDER GENERAL ANESTHESIA TO REMOVE AND REPLACE A DYSFUNCTIONAL PERITONEAL CATHETER WITH THE PRODUCT. IN THE FIRST ATTEMPT, RIGHT INTERNAL JUGULAR VEIN WAS THE FIRST CHOSEN INSERTION SITE HOWEVER AS THEY TRIED TO PLACE THE CATHETER, IT CAUSED A BRUISE AND IT WAS CORRECTED BY PRESSING WITH FINGERS ON THE PUNCTURE SITE TO STOP THE BLEEDING AND TO DECREASE THE BRUISE. IT WAS DECIDED TO CHANGE TO LEFT INTERNAL JUGULAR VEIN AND THE CATHETER WAS INTRODUCED HOWEVER ONLY THE VENOUS (BLUE) LINE HAD A RETURN FLOW. A REQUEST WAS MADE FOR RX DE TORAX (CHEST X-RAY) TO SEE THE POSITION OF THE TIP AND DETECTED THE TIP OF THE CATHETER WAS KINKED. IT WAS DECIDED TO END THE PROCEDURE AND REQUEST SUPPORT FOR ANGIOLOGY TO REMOVE THE PRODUCT. IT WAS ALSO MENTIONED THAT GUIDE WIRE HAD BECAME ENTANGLED/KINKED/BENT IN THE TIP (THE SEGMENT THAT ENTERS TO THE INTRALUMINAL SPACE OF THE CATHETER) DURING THE ACCESS PLACEMENT. THERE WAS DIFFICULTY ENCOUNTERED WHILE REMOVING THE GUIDE W IRE. IT WAS STATED THAT THE GUIDEWIRE AND CATHETER WERE REMOVED FROM THE PATIENT AT THE SAME TIME. THE GUIDE WIRE FROM THE KIT WAS USED/UTILIZED.

  Patient problems: Hematoma

  MAUDE report 10545564 ↗
• MalfunctionMar 26, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, PRIOR TO INSERTION, WHEN THEY TRIED TO PASS THE GUIDE WIRE THROUGH THE LUMEN, IT WAS FOUND THAT THE ARTERIAL LUMEN WAS "COVERED" AND DID NOT ALLOW THE GUIDE WIRE TO PASS. IT WAS REPORTED THAT THE DEVICE WAS FLUSHED WITH SALINE PRIOR TO USE. THE SALINE PASSED THROUGH THE LUMEN BUT THE NURSE FELT THAT THE LUMEN WAS A LITTLE OCCLUDED. NOTHING UNUSUAL WAS OBSERVED ON THE GUIDE WIRE AND THE GUIDE WIRE THAT WAS USED WAS THE ONE THAT CAME FROM THE KIT AND THERE WAS NO PROBLEM WITH THE CATHETERS DIMENSION AND IT MATCHED THE DIMENSION PRINTED ON THE LABEL. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9887168 ↗
• MalfunctionMar 2, 2020Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRIOR TO USE (DURING TESTING), THE VENOUS (BLUE) LINE WAS FOUND TO BE BLOCKED WHEN THE GUIDE WIRE WAS PASSED OVER THE LUMEN. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. SALINE SOLUTION WAS USED TO MOISTEN THE CATHETER AND FLUSHING WAS PERFORMED PRIOR TO INSERTION. THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE (ONLY THE INSTALLATION KIT). THEY HAD TO CHANGE THE CATHETER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9775698 ↗
• MalfunctionFeb 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING THE SCHEDULED HEMODIALYSIS SESSION, LIQUID WAS LEAKING FROM THE LUMENS UNION (JUNCTION OF EXTENSION TUBE AND BIFURCATE). THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9746736 ↗
• MalfunctionFeb 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING THE SCHEDULED HEMODIALYSIS SESSION, LIQUID WAS LEAKING FROM THE LUMENS UNION (JUNCTION OF EXTENSION TUBE AND BIFURCATE). THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9746695 ↗