MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSOSTAR NAV CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D140401
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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 product investigation was completed.Device evaluation details: the device was returned for evaluation.Biosense webster (bwi) conducted a visual inspection evaluation, and outer dimensions of the returned device.Visual analysis of the returned device revealed a damage on shaft and internal parts were exposed; however, it could be related to the handling.A dimensional outer was performed, and all dimensional values were within specifications.A manufacturing record evaluation was performed for the finished device 31302673l number, and no internal action related to the complaint were found during the review.Only the bent shaft described by the customer was confirmed.The potential cause of the damage observed cannot be established.In the manufacturing process there is evidence that the device was manufactured in accordance with documented specifications and procedures, it could be related to the handling of the device during the procedure.As part of the 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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a lassostar nav circular mapping catheter and post procedure the bwi product analysis lab identified a damage on shaft and internal parts were exposed.During the cryoablation, the catheter would not fit through the balloon and became bent.There was resistance during insertion.There were no wires exposed or lifted/sharpened rings.When the catheter was replaced, the issue was resolved.No patient consequences were reported.

• Brand Name: LASSOSTAR NAV CIRCULAR MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20270036
• Report Number: 2029046-2024-03171
• Device Sequence Number: 17952034
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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: 05/23/2025
• Device Catalogue Number: D140401
• Device Lot Number: 31302673L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC ARCTIC FRONT ADVANCE.
• Patient Sex: Unknown