AVANTI 504608XRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705032010153), received between Apr 8, 2020 and Apr 8, 2026 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 reports).

2 other recalls cover devices cleared under the same FDA submission (K970392); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Stretched; Unraveled Material

  AS REPORTED, AFTER OPENING THE 8F AVANTI + CATHETER SHEATH INTRODUCER (CSI) PACKAGE, WIRE STRETCHING/FRAYING WAS FOUND ON THE GUIDEWIRE BEFORE USE. THE DEVICE WAS NO USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823800 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A CIRCULAR FRAGMENT APPROXIMATELY 2MM IN SIZE CAME OFF OF AN 8F 11CM AVANTI+ CATHETER SHEATH INTRODUCER (CSI) WHILE THE CATHETER WAS BEING PREPARED AND FLUSHED WITH HEPARINIZED SALINE. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE OCCURRED DURING PREPARATION OF THE DEVICE. ONLY ONE CATHETER EXPERIENCED THE ISSUE DURING PREPARATION, AND ALL OTHER DEVICES FROM THE SAME LOT WERE SUBSEQUENTLY REMOVED FROM THE SHELF. THE DEVICE HAD BEEN STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DEVICE OR PACKAGE DAMAGE WAS NOTED PRIOR TO USE. THERE WAS NO INTERACTION WITH ANOTHER DEVICE OR INSTRUMENT THAT CONTRIBUTED TO THE SEPARATION, AND THE USER WAS TRAINED IN THE PREPARATION OF THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT PREVIOUSLY DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850602 ↗
• InjuryJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AN 8F 11 CM AVANTI PLUS SHEATH INTRODUCER WITH MINI-GUIDEWIRE WAS CUT DURING REMOVAL AT THE END ON AN ATRIAL FIBRILLATION PROCEDURE AND THE TIP REMAINED IN THE PATIENT'S FEMORAL VEIN. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR EXPLORATION OF THE RIGHT FEMORAL VEIN AND REMOVAL OF THE SEVERED TIP. IT IS UNKNOWN WHETHER AN INTERVENTIONAL RADIOLOGY (IR) PROCEDURE TO REMOVE THE SEPARATED SHEATH SEGMENT WAS PERFORMED THE SAME DAY, AND NO DETAILS WERE GIVEN ABOUT THE TIMING IF IT OCCURRED LATER. AFTER REMOVAL OF THE SEPARATED SEGMENT, THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION, ALTHOUGH THE HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. A CONTRALATERAL APPROACH WAS NOT USED DURING THE PROCEDURE. THE DEVICE WAS FLUSHED PRIOR TO USE; HOWEVER, THE VESSEL DILATOR WAS NOT SNAPPED INTO PLACE AT THE HUB. THE PROCEDURE WAS SUCCESSFULLY PERFORMED PRIOR TO THE REMOVAL OF THE AVANTI PLUS CSI. ALTHOUGH THE CSI WAS REMOVED TO EXCHANGE FOR ANOTHER SHEATH, THERE WAS NO INFORMATION PROVIDED REGARDING RESISTANCE DURING REMOVAL.NO PROCEDURAL IMAGES OR CDS ARE AVAILABLE FOR REVIEW. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541439 ↗
• InjuryNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, UPON REMOVING ONE 8F 11CM AVANTI + CATHETER SHEATH INTRODUCER, 3/4 OF THE PROXIMAL SHEATH WAS REMOVED FROM THE ARTERY, BUT THE REMAINING 1/4 OF THE DISTAL SHEATH HAD SEPARATED COMPLETELY AND REMAINED IN THE FEMORAL ARTERY. A VASCULAR SURGEON ATTENDED AND USED A LONG MUSTANG BALLOON TO SNARE AND RETRIEVE THE BROKEN DISTAL TIP OF THE SHEATH WITHOUT ADVERSE EFFECTS. THE OTHER AVANTI + SHEATH WAS REMOVED WITHOUT ISSUE. THE PATIENT WAS UNHARMED. THERE WERE NO REPORTS OF PATIENT INJURY. THE TWO 8F AVANTI SHEATHS WERE INSERTED INTO THE FEMORAL ARTERIES DURING AN ELECTROPHYSIOLOGICAL CARDIOLOGY PROCEDURE. THE NURSE UNIT MANAGER COMMUNICATED IT IS POSSIBLE THE SECOND DOCTOR NICKED THE SHEATH WITH THE SCALPEL, AND A CALL WAS PLACED TO CONFIRM WHAT HIS USUAL PRACTICE IS. DURING THE PROCEDURE, ONLY ONE SHEATH MALFUNCTIONED. THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). A CONTRALATERAL APPROACH WAS NOT USED. THE PATIENT WAS A THIN FEMALE WITH VERY TOUGH FASCIA, MAKING ACCESS DIFFICULT. THE SURGEON KINKED THE SHEATH DURING ACCESS AND DID NOT USE MOSQUITO FORCEPS TO CREATE A W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797139 ↗
• InjuryAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THERE HAS BEEN A RUPTURE OF THE 8F AVANTI + STANDARD SHEATH INTRODUCER IN THE PATIENT'S VEIN. THIS INCIDENT NECESSITATED AN ANGIOSCAN TO SEARCH FOR AND EXTRACT A FOREIGN BODY, CONSEQUENTLY RESULTING IN A PROLONGED HOSPITALIZATION OF THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055148 ↗
• InjuryApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AN 8F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) SEPARATED WHEN IT WAS BEING WITHDRAWN FROM THE PATIENT AND THE SEPARATED SEGMENT REMAINED IN THE PATIENT. TWO ADDITIONAL VENOUS ACCESS SITES WERE OBTAINED TO REMOVE THE SEPARATED CSI SEGMENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200826 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE DOCTOR, THE HEMOSTASIS VALVE HUB (WHITE PIECE) ON THE 8F AVANTI PLUS SHEATH INTRODUCER WITH MINI-GUIDEWIRE BECAME SEPARATED AND THE PATIENT STARTED TO BLEED OUT. THE PATIENT WAS FINE. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED DURING ANY PART OF THE PROCEDURE NOR RESISTANCE MET WHILE ADVANCING THE DEVICE. THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THERE WAS NO EXCESSIVE TORQUING REQUIRED. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT; EXCEPT FOR THE HUB WHICH WAS OUTSIDE THE BODY. THE SEPARATION WAS NOT RELATED TO ANY RESISTANCE DURING WITHDRAWAL OF THE SHEATH FROM THE VESSEL AND THE SHEATH HAD NOT KINKED OR BEEN TWISTED/TORQUED PRIOR TO THE SEPARATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153125 ↗
• InjuryAug 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED AFTER INSERTION OF THE 8F AVANTI SHEATH INTRODUCER 0.035¿X23CM INTO THE FEMORAL ARTERY, THE AVANTI SHEATH BROKE APART INSIDE THE PATIENT. THE FRAGMENTS NEEDED TO BE REMOVED OPERATIVELY. THE PUNCTURE PLACE WAS OPENED AND ALL THE FRAGMENTS WERE ABLE TO BE REMOVED WITH A TWEEZER. THIS HAPPENED TWICE ON THE SAME PATIENT; LEFT AND RIGHT FEMORAL ARTERY. THE INTENDED PROCEDURE WAS REPORTED TO BE A PULMONARY VEIN ISOLATION (PVI). THE ACCESS SITE WAS FEMORAL. THERE WAS NO CALCIFICATION OR TORTUOSITY AND THE PERCENTAGE STENOSIS IS UNKNOWN. A CONTRALATERAL APPROACH WAS NOT USED. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCTS WERE REMOVED FROM THE PACKAGING. THE PRODUCTS WERE STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES WHICH WERE FLUSHED PRIOR TO USE. THE VESSEL DILATOR SNAPPED INTO PLACED AT THE HUB. THERE WAS NO DIFFICULTY DURING THE INSERTION PROCESS. THE PATIENT WAS HOSPITALIZED FOR THE PVI PROCEDURE; HOWEVER, EXTENDED HOSPITALIZATION WAS NOT REQUIRED FOR THIS EVENT. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION. TWO DEVICE IMAGES WERE PROVIDED FOR REVIEW. THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467141 ↗
• InjuryAug 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED AFTER INSERTION OF THE 8F AVANTI SHEATH INTRODUCER 0.035¿X23CM INTO THE FEMORAL ARTERY, THE AVANTI SHEATH BROKE APART INSIDE THE PATIENT. THE FRAGMENTS NEEDED TO BE REMOVED OPERATIVELY. THE PUNCTURE PLACE WAS OPENED AND ALL THE FRAGMENTS WERE ABLE TO BE REMOVED WITH A TWEEZER. THIS HAPPENED TWICE ON THE SAME PATIENT; LEFT AND RIGHT FEMORAL ARTERY. THE INTENDED PROCEDURE WAS REPORTED TO BE A PULMONARY VEIN ISOLATION (PVI). THE ACCESS SITE WAS FEMORAL. THERE WAS NO CALCIFICATION OR TORTUOSITY AND THE PERCENTAGE STENOSIS IS UNKNOWN. A CONTRALATERAL APPROACH WAS NOT USED. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCTS WERE REMOVED FROM THE PACKAGING. THE PRODUCTS WERE STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES WHICH WERE FLUSHED PRIOR TO USE. THE VESSEL DILATOR SNAPPED INTO PLACED AT THE HUB. THERE WAS NO DIFFICULTY DURING THE INSERTION PROCESS. THE PATIENT WAS HOSPITALIZED FOR THE PVI PROCEDURE; HOWEVER, EXTENDED HOSPITALIZATION WAS NOT REQUIRED FOR THIS EVENT. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION. TWO DEVICE IMAGES WERE PROVIDED FOR REVIEW. THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467140 ↗
• MalfunctionJul 31, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF AN 8F AVANTI SHEATH CATHETER SHEATH INTRODUCER (CSI) WAS SPLIT DURING THE PUNCTURE BECAUSE THE TIP END OF THE SHEATH WAS TOO SOFT. THE SURGEON REPLACED THE ISSUE PRODUCT WITH A NEW ONE. THE NEW SHEATH HAD THE SAME PROBLEM TOO. THEN THE SURGEON REPLACED IT WITH ANOTHER ONE AND THE THIRD ONE WAS USED NORMALLY. THREE SHEATHS FROM THE SAME CATALOG WERE USED IN THE PROCEDURE. THE VESSEL DILATOR WAS NOT SNAPPED INTO PLACE AT THE HUB. THERE WAS NO ISSUE SNAPPING THE DILATOR INTO PLACE. NO PHYSICAL INJURY WAS CAUSED TO THE PATIENT, BUT IT CAUSED DISTRESS TO THE OPERATOR. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU. A CONTRALATERAL APPROACH WAS USED. THE ACCESS SITE WAS NOT TORTUOUS AND HAD NO CALCIUM. THE DEVICE WAS FLUSHED PRIOR TO USE. THE ACCESS SITE WAS PRE DILATED. THE PATIENT WAS TRANSFERRED TO THE DEPARTMENT FROM THE CATHETERIZATION LABORATORY WITH A DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION. DUE TO CRITICAL CONDITION, THE AORTIC BALLOON CATHETER WAS PUNCTURED. THE AORTIC BALLOON COUNTERBORE WAS CONNECTED IMMEDIATELY AND THE PROCEDURE WAS SUCCESSFUL. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. THE DEVICE IS BEING RETURNE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423934 ↗
• MalfunctionJul 31, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF AN 8F AVANTI SHEATH CATHETER SHEATH INTRODUCER (CSI) WAS SPLIT DURING THE PUNCTURE BECAUSE THE TIP END OF THE SHEATH WAS TOO SOFT. THE SURGEON REPLACED THE ISSUE PRODUCT WITH A NEW ONE. THE NEW SHEATH HAD THE SAME PROBLEM TOO. THEN THE SURGEON REPLACED IT WITH ANOTHER ONE AND THE THIRD ONE WAS USED NORMALLY. THREE SHEATHS FROM THE SAME CATALOG WERE USED IN THE PROCEDURE. THE VESSEL DILATOR WAS NOT SNAPPED INTO PLACE AT THE HUB. THERE WAS NO ISSUE SNAPPING THE DILATOR INTO PLACE. NO PHYSICAL INJURY WAS CAUSED TO THE PATIENT, BUT IT CAUSED DISTRESS TO THE OPERATOR. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU. A CONTRALATERAL APPROACH WAS USED. THE ACCESS SITE WAS NOT TORTUOUS AND HAD NO CALCIUM. THE DEVICE WAS FLUSHED PRIOR TO USE. THE ACCESS SITE WAS PRE DILATED. THE PATIENT WAS TRANSFERRED TO THE DEPARTMENT FROM THE CATHETERIZATION LABORATORY WITH A DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION. DUE TO CRITICAL CONDITION, THE AORTIC BALLOON CATHETER WAS PUNCTURED. THE AORTIC BALLOON COUNTERBORE WAS CONNECTED IMMEDIATELY AND THE PROCEDURE WAS SUCCESSFUL. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. THE DEVICE IS BEING RETURNE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423860 ↗
• InjuryJul 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PHYSICIAN USED TWO DIFFERENT AVANTI SHEATHS. THE 9F AVANTI SHEATH BENT AND THE 8F AVANTI SHEATH SEPARATED IN THE PATIENT. THE SEPARATION WAS NOTICED WHEN IT WAS INSERTED INTO THE PATIENT, IT THAN BROKE AS THE INNER PART WAS BEING REMOVED. THE SHEATH SEPARATED INTO TWO DIFFERENT PIECES. THE PIECE WAS REMOVED FROM THE PATIENT WITH A SNARE. ONCE THE PIECE WAS REMOVED FROM THE PATIENT, NEW CORDIS SHEATHS WERE PLACED, AND THE PROCEDURE WAS COMPLETED PER USUAL. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED IN A DRAWER IN THE BOX. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICES WERE TAKEN OUT OF THE PACKAGE. THE DEVICES WERE PREPPED PER THE IFU WITH NO DIFFICULTY REPORTED. THE ACCESS SITE WAS THE FEMORAL VENOUS. THE INTENDED PROCEDURE WAS AN AFIB ABLATION VIA THE FEMORAL VEIN. THE LESION DID NOT HAVE ANYTHING UNUSUAL. UNUSUAL FORCE WAS NOT USED AT ANY TIME DURING THE PROCEDURE. THE SHEATHS WERE NOT TORQUED AGAINST RESISTANCE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316748 ↗
• MalfunctionMar 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HEMOSTASIS VALVE OF AN 8F WITH MINI-GUIDEWIRE AVANTI+ CATHETER SHEATH INTRODUCER (CSI) SEPARATED DURING THE RETRIEVAL OF THE DILATOR. AIR EMBOLIZATION AND BLOOD BACK FLOW THROUGH FROM THE DAMAGED VALVE WAS PREVENTED BY FINGER OCCLUSION OF THE OPENING. THE PROCEDURE HAS BEEN COMPLETED WITH ANOTHER UNKNOWN VASCULAR ACCESS WITHOUT ANY OTHER COMPLICATION. THE INTRODUCER WAS THEN REMOVED, AND HEMOSTASIS OBTAINED BY DIRECT COMPRESSION. THERE WAS NO REPORT PATIENT INJURY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS PLACED IN THE JUGULAR VEIN TO CARRY OUT AN INTERVENTIONAL PROCEDURE FOR A TRANSCATHETER ABLATION OF AN ATRIAL FIBRILLATION. THE ACCESS VESSEL WAS NOT CALCIFIED NOR TORTUOUS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538994 ↗
• MalfunctionJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AFTER ACCESS INTO THE RIGHT FEMORAL VEIN WITH THE AVANTI SHEATH, THE PHYSICIAN WAS REMOVING THE SHEATH DILATOR AND WHEN HE REMOVED THE DILATOR, THE BACK PORTION OF THE INTRODUCER SHEATH WAS REMOVED AS WELL LEAVING THE PROXIMAL PORTION OF THE SHEATH FLOATING IN THE PATIENT'S BODY. THE PATIENT WENT THROUGH A LENGTHY PROCEDURE TO RETRIEVE THE REMAINDER OF THE SHEATH. THE INITIAL PROCEDURE THAT THE PATIENT WAS ORIGINALLY SCHEDULED FOR (AFIB ABLATION), WHICH WAS ABORTED DUE TO THE TIME SPENT ON THE SHEATH RETRIEVAL. THE DAMAGED SHEATH AND THE PIECE THAT WAS RETRIEVED WERE NOT SAVED. ADDITIONAL INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854489 ↗
• InjuryMar 14, 2022Partial Blockage; Disconnection; Material Separation; Obstruction of Flow; Detachment of Device or Device Component; Partial Blockage; Detachment of Device or Device Component

  AS REPORTED, THE AVANTI PLUS CATHETER SHEATH INTRODUCER (SI AVANTI+ 8F STD W/GW NO OBT) FELL OFF (SEPARATED) FROM A PATIENT AND THERE WAS BLOOD RETURN. THE PATIENT'S HEART RATE AND BLOOD PRESSURE DID NOT CHANGE AT THAT TIME AND SMALL CLIPS WERE USED TO CLIP THE ARTERIAL COLLATERALS AND REFLEX THE CATHETER TO PREVENT BLEEDING. THE PATIENT WAS REPORTED TO HAVE BEEN INITIALLY ADMITTED DUE TO ACUTE CORONARY SYNDROME AND WAS PLACED IN AN INTRA-AORTIC BALLOON PUMP (IABP). THE PUMP WAS SUBSEQUENTLY REPLACED WITH A FIXED CATHETER (THE AVANTI PLUS CATHETER) WHICH WAS FOUND DISCONNECTED FROM THE PATIENT AT BEDTIME. THE COLLATERAL CATHETER WAS IMMEDIATELY REVERSED, AND THE EVENT WAS REPORTED TO THE DOCTOR AND HEAD NURSE. ACCORDING TO THE ADDITIONAL INFORMATION PROVIDED, THE PATIENT WAS REPORTED TO HAVE BEEN HOSPITALIZED DUE TO ACUTE MYOCARDIAL INFARCTION AND ACUTE THROMBOEMBOLISM AND UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) VIA THE ANTERIOR DESCENDING BRANCH. THE LESION WAS NOT CALCIFIED; THERE WAS NO VESSEL TORTUOSITY AND NINETY-PERCENT STENOSIS. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRU

  Patient problems: Insufficient Information

  MAUDE report 13758832 ↗
• MalfunctionSep 13, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING PREP BEFORE A RADIOFREQUENCY ABLATION PUNCTURE, HAIR WAS FOUND AT THE DISTAL END OF THE 8F STANDARD (STD) AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) WITH GUIDEWIRE (GW) NO OBTURATOR (OBT). THERE WAS A "BLACK OBJECT" ON THE DISTAL END OF THE DEVICE; SIMILAR TO HAIR. THE DEVICE WAS REPLACED IMMEDIATELY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO ADVERSE EVENT WITH THIS REPORTED ISSUE. THIS WAS NOTICED DURING PREP, WHEN THE DEVICE WAS OUT OF THE PACKAGE. THE DEVICE WAS STORED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE STERILE PACKAGING. THE PRODUCT HAD NOT BEEN RESHELVED AFTER PREVIOUS OPENING IN ANTICIPATION OF USE. STERILE PROTOCOL WAS MAINTAINED IN THE PROCEDURE ROOM. THE HOSPITAL HAS CHOSEN TO REPORT THIS AS AN ADVERSE EVENT TO THE NMPA DIRECTLY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458869 ↗
• MalfunctionDec 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE CATHETER OF 8F STANDARD (STD) AVANTI PLUS WITH GUIDEWIRE NO OBTURATOR SHEATH INTRODUCER WAS BLOCKED. THERE WAS NO REPORTED PATIENT INJURY. ANALYSIS OF THE RETURNED DEVICE INDICATED THE CAP OF THE HUB WAS FOUND ON THE VESSEL DILATOR SEPARATED FROM THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11036903 ↗
• MalfunctionJun 10, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, IT WAS NOTED THAT THERE ARE DROPS OF FLUID INSIDE THE STERILE PACKAGE OF A 5F AVANTI PLUS STANDARD (STD) SHEATH INTRODUCER. IT IS NOTED THAT IT IS A CONDENSE WATER AND IT IS MOSTLY THE EXPLANATION. THERE WAS NO REPORTED PATIENT INJURY. NO DAMAGES WERE NOTED TO PACKAGING OF THE DEVICE. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. AN IMAGE HAS BEEN ATTACHED FOR REVIEW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140504 ↗
• InjuryApr 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AT THE END PART OF AN ABLATION CASE DURING THE REMOVAL OF THE 8F 13CM AVANTI PLUS STANDARD (STD) WITH GUIDEWIRE NO OBTURATOR (OBT) SHEATH INTRODUCER, THE DEVICE WAS FOUND TO BE BROKEN AND THE DISTAL 4CM OF THE SHEATH WAS MISSING AFTER THE PROCEDURE. A FLUOROSCOPY WAS MADE AT THE PULMONARY ARTERY TO VISUALIZE THE DETACHED END OF THE SHEATH AND IT WAS SUCCESSFULLY REMOVED USING A SNARE. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO OBVIOUS CAUSE OF THE BROKEN SHEATH. THE PHYSICIAN VERBALIZED THAT IT IS POSSIBLE THAT WHILE REMOVING THE HD GRID CATHETER FROM THE BODY, THE 13CM AVANTI SHEATH BECAME TANGLED WITH THE HD GRID AND BROKE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935751 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970392. One submission often covers many models, so check the product and lot details in each record.

• Z-2079-2021 · Jun 9, 2021 · Terminated
  Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
• Z-1174-2016 · Dec 31, 2015 · Terminated
  CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneo