MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE; INTRODUCER, CATHETER

Model Number 301803M

Device Problems Material Perforation (2205); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an afib ¿ paroxysmal ablation procedure with a preface® guiding sheath with multipurpose curve and a perforation on the sheath occurred.It was reported that during the procedure, when advancing with the preface® guiding sheath with multipurpose curve and needle to perform the transseptal puncture, the team encountered a lot of difficulty in the process.Upon analyzing the image on intracardiac echo, they noticed that the needle had pierced the tip of the preface® guiding sheath with multipurpose curve, making it no longer usable.So, they replaced the sheath with another one and proceeded with the procedure.The surgery was delayed about 15 minutes due to the reported event.They replaced the perforated sheath and completed the procedure successfully.No fragments were generated.No patient consequences were reported.Additional information was received on the event.The damage did not result in wires and/or braid being exposed, just the needle making a little hole by the tip of preface® guiding sheath with multipurpose curve.The damage did not result in any lifted or sharp rings.There was resistance and difficulty, it was a difficult procedure right from the beginning.Maybe that procedural difficultly collaborated to the problem.There was no detached portion of any of the materials.There was only the hole by the tip preface® guiding sheath with multipurpose curve made by the needle (heartspan).No detached parts.They thought that the perforation of the device was caused by a mix of the technical difficult procedure in accessing the veins of the patient, the very soft and flexible tip of the preface® guiding sheath with multipurpose curve and the hard tissue that the atria septum of the patient was made.The perforation on the sheath was assessed as mdr reportable.The resistance with sheath issue was assessed as not mdr reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an afib ¿ paroxysmal ablation procedure with a preface® guiding sheath with multipurpose curve and a perforation on the sheath occurred.It was reported that during the procedure, when advancing with the preface® guiding sheath with multipurpose curve and needle to perform the transseptal puncture, the team encountered a lot of difficulty in the process.Upon analyzing the image on intracardiac echo, they noticed that the needle had pierced the tip of the preface® guiding sheath with multipurpose curve, making it no longer usable.So, they replaced the sheath with another one and proceeded with the procedure.The surgery was delayed about 15 minutes due to the reported event.They replaced the perforated sheath and completed the procedure successfully.No fragments were generated.No patient consequences were reported.Additional information was received on the event.The damage did not result in wires and/or braid being exposed, just the needle making a little hole by the tip of preface® guiding sheath with multipurpose curve.The damage did not result in any lifted or sharp rings.There was resistance and difficulty, it was a difficult procedure right from the beginning.Maybe that procedural difficultly collaborated to the problem.There was no detached portion of any of the materials.There was only the hole by the tip preface® guiding sheath with multipurpose curve made by the needle (heartspan).No detached parts.They thought that the perforation of the device was caused by a mix of the technical difficult procedure in accessing the veins of the patient, the very soft and flexible tip of the preface® guiding sheath with multipurpose curve and the hard tissue that the atria septum of the patient was made.The perforation on the sheath was assessed as mdr reportable.The resistance with sheath issue was assessed as not mdr reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.

Manufacturer Narrative

The investigation was completed on 09-mar-2022.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 17965987 number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13202496
• MDR Text Key: 286258362
• Report Number: 2029046-2022-00056
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: 10846835000047
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 301803M
• Device Catalogue Number: 301803M
• Device Lot Number: 17965987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON BWI-HEARTSPAN NEEDLE; UNKNOWN BRAND SHEATH