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

Model Number	D606DR002RT
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster¿ electrophysiology catheter and issues with internal components exposed as well as a missing electrode occurred.When the webster catheter was taken out of the package, they noticed that a third electrode was missing, exposing the wire underneath.It was not the anchor window but a wire protruding from the catheter itself upon opening.The catheter was not used in the patient and not inserted into a dilator or the sheath.The damage was noted upon opening of the package and was not used in the field.There was no physical damage to the packaging and the device was properly secured in the tray.The catheter was replaced, and the issue resolved.No adverse patient consequence was reported.The issues of internal components exposed and the missing electrode were assessed as a mdr reportable product malfunction.
Additional Manufacturer Narrative
The device evaluation was completed on 11-apr-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster¿ electrophysiology catheter and issues with internal components exposed as well as a missing electrode occurred.When the webster catheter was taken out of the package, they noticed that a third electrode was missing, exposing the wire underneath.It was not the anchor window but a wire protruding from the catheter itself upon opening.The catheter was not used in the patient and not inserted into a dilator or the sheath.The damage was noted upon opening of the package and was not used in the field.There was no physical damage to the packaging and the device was properly secured in the tray.The catheter was replaced, and the issue resolved.No adverse patient consequence was reported.The product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the electrodes were found with no damages on the webster¿ electrophysiology catheter.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.The instructions for use contain the following recommendations: for use with compatible rf generators, carto¿3system and biosense webster cables, and other appropriate interface cables and connectors.A manufacturing record evaluation was performed for the finished device number 30594591m, and no internal actions related to the complaint were 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: pc-(b)(4).

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13786326
• Report Number: 2029046-2022-00545
• Device Sequence Number: 16552343
• Product Code: DRF
• UDI-Device Identifier: 10846835004212
• UDI-Public: 10846835004212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2024
• Device Model Number: D606DR002RT
• Device Catalogue Number: D606DR002RT
• Device Lot Number: 30594591M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK BRAND CATHETER
• Patient Sex: Unknown