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

Model Number	D140401
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lassostar nav catheter product was returned to biosense webster for evaluation.Bwi conducted a visual inspection test of the returned device.Visual analysis of the returned sample revealed that the shaft was observed bent in one area and broken in another area, these damages were observed in the middle of the shaft.The root cause of the shaft broken and bent could be related to the usage of the device during the procedure, however, this cannot be conclusively determined.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a lassostar nav circular mapping catheter for which biosense webster¿s product analysis lab (pal) identified the shaft broken.Pvi it was impossible to introduce the lassostar nav circular mapping catheter through the inner lumen past a certain point.The lassostar nav circular mapping catheter was snapped in the process of attempting to introduce it.Used a new lassostar.Five minute delay.No patient consequence reported.Additional information was received.A y-adaptor was connected to the heliostar catheter.There was no occlusion when irrigating the heliostar catheter.The sheath / heliostar was not in a deflected state.It was during the preparation of the balloon.No damaged rings.The heliostar catheter did not narrow, did not partially block nor completely blocked.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.The catheter was not pre-shaped.Clarification to the event which was originally reported as ¿snapped¿ was received.The reporter states ¿it was bent¿.The event was assessed as non mdr reportable for a bent tip issue.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, 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 observed bent in one area and broken in another area.The shaft broken was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 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: 16968144
• Report Number: 2029046-2023-01082
• Device Sequence Number: 17490918
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 05/18/2023

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: 04/29/2023
• Device Model Number: D140401
• Device Catalogue Number: D140401
• Device Lot Number: 30777308L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10.5FR 28MM BALLOON ABLAT CATH; UNK_LASSOSTAR CATHETER
• Patient Sex: Unknown