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

Catalog Number	D160902
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 15-jul-2024.The device evaluation summary: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and functionality test of the returned device were performed following bwi procedures.Visual analysis revealed two splines bent and broken with internal parts exposed on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly.No visualization or mapping issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The magnetic issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Besides, the potential cause of the broken tip could not be established, since this condition could have been caused by post-operative handling or the subsequent handling of the device to have it decontaminated as this damage is not covered in the reported event description.The carto instructions for use (ifu) state: the magnetic sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.As part of biosense webster's 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 ¿magnetic sensor error¿ issue.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to biosense webster inc.Analysis finding of the ¿two splines bent and broken with internal parts exposed¿.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with octaray mapping catheter for which biosense webster¿s product analysis lab (pal) identified two splines bent and broken with internal parts exposed.Initially it was reported that a magnetic sensor error occurred.Timing was when inserting the octaray mapping catheter into the patient's body.Reconnecting the cable and replacing the cable did not resolve the issue.Upon the physician's decision, switched to decanav to perform the procedure.Then, the procedure was successfully completed without any problems.No patient consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 14-aug-2024, two splines were bent and broken with internal parts exposed on the device.The event was originally considered non-reportable, however, bwi became aware of two splines bent and broken with internal parts exposed on 14-aug-2024 and have assessed this returned condition as reportable.

• Brand Name: OCTARAY MAPPING CATHETER
• 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: 20190798
• Report Number: 2029046-2024-03030
• Device Sequence Number: 17840668
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: (01)10846835021110(11)230627(17)240626(10)31097489L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193237
• 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): 09/11/2024

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: 06/26/2024
• Device Catalogue Number: D160902
• Device Lot Number: 31097489L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK CABLE.
• Patient Sex: Unknown