MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D128210
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 13-aug-2024.The device evaluation details: the pentaray nav eco device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device were performed following bwi procedures.Visual analysis revealed a spline bent and an electrode lifted and dented.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The spline bent reported by the customer was confirmed.The potential cause of the spline bent and the electrode lifted could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.The device instructions for use contain the following recommendations: - the catheter is recommended for use with an 8 f guiding sheath because the distal splines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25 mm in diameter.- do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿the splines of the catheter were found bent when the package was just opened¿ issue.-investigation findings: stress problem identified (c0706))/ investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the ¿electrode lifted and dented¿.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a pentaray nav for which biosense webster¿s product analysis lab (pal) identified an electrode lifted.Device damaged.Before the procedure, the splines of the catheter were found bent when the package was just opened.A second device was used to complete the procedure.There was no adverse event reported on the patient.Device was not used in patient.Additional information was received.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 20-aug-2024, the spline was bent and an electrode was lifted and dented.The event was originally considered non-reportable, however, bwi became aware of an electrode lifted on 20-aug-2024 and have assessed this returned condition as reportable.

• Brand Name: PENTARAY NAV
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 20220201
• Report Number: 2029046-2024-03088
• Device Sequence Number: 7450942
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: (01)10846835012248(17)260622(10)31093538L
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123837
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2024

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: 06/22/2026
• Device Catalogue Number: D128210
• Device Lot Number: 31093538L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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