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

Catalog Number	F6ADP282RT
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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).
Additional 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
• Common Device Name: 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
• Report Number: 2029046-2023-01599
• Device Sequence Number: 14966044
• Product Code: LDF
• UDI-Device Identifier: 10846835007534
• UDI-Public: 10846835007534
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2025
• Device Catalogue Number: F6ADP282RT
• Device Lot Number: 30930695M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown