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	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and functional test of the returned device were performed following bwi procedures.Visual analysis revealed the shaft and tip with a wrinkled texture, and electrode lifted with edges.The root cause of the damage could be related to the impeded issue during the handling.A dimensional test was performed, and outer diameters of the device were found within specifications, however, due to the physical condition of the returned device, the issue could be attributed to the reported event.The issue reported by the customer was confirmed.Product failure is multifactorial.A manufacturing record evaluation was performed for the finished device, and no internal actions was found during the review.As part of biosense webster's 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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a lassostar nav circular mapping catheter for which biosense webster¿s product analysis lab (pal) identified the shaft and tip with a wrinkled texture, and electrode lifted with edges.It was initially reported by the customer that the lassostar nav circular mapping catheter has become stuck inside the lumen of the heliostar balloon catheter.There was no patient consequence and no other details about the event were provided.As such, the event was assessed as a not reportable malfunction since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 12-dec-2023, the bwi pal revealed that a visual inspection of the returned device found the shaft and tip with a wrinkled texture, and electrode lifted with edges.These findings were reviewed and assessed the issue of damage on the electrode to be an mdr reportable malfunction.
Additional Manufacturer Narrative
On (b)(6) 2024, additional information was received indicating the y-adaptor connected to the heliostar catheter.The sheath/heliostar were not in a deflected state.No damage was observed with the rings.The heliostar catheter was completely blocked and there was resistance felt with both devices during insertion or retraction.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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: 18441464
• Report Number: 2029046-2024-00049
• Device Sequence Number: 8145541
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 01/03/2024

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: 07/24/2025
• Device Catalogue Number: D140401
• Device Lot Number: 31086545L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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: 10.5FR 28MM BALLOON ABLAT CATH
• Patient Sex: Unknown