MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV DS; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BN7TCDF8L
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation 19-aug-2024.The device evaluation details: the product was returned to johnson and johnson medtech for evaluation.Johnson and johnson medtech conducted a visual inspection and deflection evaluation of the returned device.Visual analysis of the returned sample revealed that there was a bent and small crack near the second ring.Deflection testing was performed and observed that the tip deflects properly.A manufacturing record evaluation was performed for the finished device 31332518m number, and no internal action was found during the review.The event described could not be confirmed as the device performed without any deflection issues.The tip condition could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.As part of johnson and johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿issue on the deflection¿.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿bent and small crack near the second ring¿.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a typical flutter ablation procedure with an ez steer nav ds for which biosense webster¿s product analysis lab (pal) identified a small crack near the second ring.During the procedure, there was an issue on the deflection of the tip of the ablation catheter.The catheter did not bend properly.Another catheter was used in order to complete the procedure successfully.Lengthening of procedure time was of approximately 3 minutes.There was no patient consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 18-sep-2024 observed it bent and small crack near the second ring.The event was originally considered non-reportable, however, bwi became aware of the small crack near the second ring on 18-sep-2024 and have assessed this returned condition as reportable.

• Brand Name: EZ STEER NAV DS
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 20407292
• Report Number: 2029046-2024-03321
• Device Sequence Number: 6480289
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: (01)10846835003000(17)270508(10)31332518M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010068/S6
• 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): 10/09/2024

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 Catalogue Number: BN7TCDF8L
• Device Lot Number: 31332518M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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