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 Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation 26-jul-2023.The device evaluation was completed on 03-aug-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed that the shaft was broken leaving wires exposed.The device was connected to the carto 3 system and it was recognized and visualized correctly.No issues or errors were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The 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.The root cause of the damage in the shaft could be related to the excessive force or manipulation of the device during the procedure; however, this can not be conclusively determined.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 ¿catheter sensor error¿.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the biosense webster inc.Analysis finding of the ¿shaft broken leaving wires exposed¿.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a lassostar nav circular mapping catheter for which biosense webster¿s product analysis lab (pal) identified the shaft broken leaving wires exposed.Initially a catheter sensor error was reported.There was no patient consequence reported.The catheter sensor error issue was assessed as non mdr reportable.The incidence of magnetic sensor error is easy detectable by the user.The catheter was inoperable, since it cannot be visualized on the carto system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2023, the shaft was broken leaving wires exposed.The shaft was broken leaving wires exposed was assessed as mdr reportable.The awareness date for this reportable lab finding was 03-aug-2023.

• 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: 17651913
• Report Number: 2029046-2023-01933
• Device Sequence Number: 17713522
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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: 04/28/2023
• Device Catalogue Number: D140401
• Device Lot Number: 30771919L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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