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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
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 dimensional inspection of the returned device were performed following bwi procedures.Visual analysis revealed the shaft was broken close to the tip transition.No additional anomalies were observed.A dimensional inspection was performed and the device was within specifications.A manufacturing investigation was requested and it was determined that the broken condition is not related to the manufacturing process since evidence of proper manufacturing assembly was found.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The lassostar issue reported by the customer was confirmed.The potential cause of the broken shaft could be related to the manipulation of the device during the procedure into the heliostar, however, this cannot be conclusively determined.The lassostar nav instructions for use contain the following recommendation: the catheter tip must be straight when it is inserted into the working lumen of a compatible catheter.Insertion of the catheter into the entry port of a compatible sheath should be conducted with the insertion tool provided with the catheter.To prevent damage to the shaft of the catheter, ensure that at least half of the catheter is inserted through the sheath before sliding the insertion tool back toward the connector.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 an atrial fibrillation (afib) ablation procedure with a lassostar nav circular mapping catheter for which biosense webster¿s product analysis lab (pal) identified the shaft was broken close to the tip transition.It was initially reported by the customer that the lassostar nav circular mapping catheter knicked while leading him into the heliostar.The issue was resolved by changing the catheter.The issue was not considered to be mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 16-may-2024, the bwi pal revealed that a visual inspection of the returned device found the shaft was broken close to the tip transition.These finding was reviewed and assessed the issue as an mdr reportable malfunction since the integrity of the device is compromised.

• 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: 19525332
• Report Number: 2029046-2024-01930
• Device Sequence Number: 18014385
• 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

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: 10/24/2024
• Device Catalogue Number: D140401
• Device Lot Number: 31169376L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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: UNK_HELIOSTAR CATHETER.
• Patient Sex: Unknown