MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number F6ADP282RT

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 06/30/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a afib - paroxysmal ablation procedure with a webster¿ electrophysiology catheter, however, prior to the operation, the tip of the catheter was found damaged (no exposed wires).A second device was used to complete the operation.There was no adverse event reported on patient.Device was not used in patient.The damaged tip is mdr-reportable.

Manufacturer Narrative

The bwi product analysis lab received a photo of the complaint device for evaluation.The photo analysis was subsequently completed.Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the tip of the catheter was observed damaged on electrode without exposed wires.Sharp rough edges were observed on the device.A manufacturing record evaluation was performed for the finished device number 30930695m, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed based on the picture received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 10-aug-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a afib - paroxysmal ablation procedure with a webster¿ electrophysiology catheter, however, prior to the operation, the tip of the catheter was found damaged (no exposed wires).A second device was used to complete the operation.There was no adverse event reported on patient.Device was not used in patient.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection was performed following bwi procedures.Visual analysis revealed that the tip of the catheter was observed damaged on electrode without exposed wires.One electrode was observed lifted.The damage observed could be related to the manipulation of the device during the procedure, however, this can not be conclusively determined a manufacturing record evaluation was performed for the finished device number lot 30930695m and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17398974
• MDR Text Key: 319792541
• Report Number: 2029046-2023-01599
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10846835007534
• UDI-Public: 10846835007534
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K892265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F6ADP282RT
• Device Lot Number: 30930695M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2022
• 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