MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSOSTAR, 10P, DIA 15MM LOOP SIZE; LASSOSTAR¿ CIRCULAR MAPPING CATHETER

Catalog Number D139001

Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 20-oct-2021.The device evaluation was completed on 08-dec-2021.The product involved: lassostar catheter.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed a bent and broken shaft with metal exposed on the lassostar catheter.The bent and broken condition noted on the device may have been related to the customer complaint and may have appeared to have been caused by excessive force and when handling is applied to the device; however, none of those can be conclusively determined.A manufacturing record evaluation was performed for the finished catheter batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated: -to maneuver the catheter, use the torque on the catheter to torque (or rotate) the shaft in a clockwise direction only.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a lassostar, 10p, dia 15mm loop size, and the biosense webster, inc.Product analysis lab observed a broken shaft with metal exposed.Initially it was reported that the wire was bended by insertion into the heliostar catheter.It was not known if the procedure was successfully completed.There was no patient consequence reported.The event was assessed as a not mdr reportable shaft bent 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 08-dec-2021 there was a bent and broken shaft with metal exposed observed.The broken shaft with metal exposed was assessed as mdr reportable.The awareness date for this reportable lab finding was on (b)(6) 2021.

• Brand Name: LASSOSTAR, 10P, DIA 15MM LOOP SIZE
• Type of Device: LASSOSTAR¿ CIRCULAR MAPPING CATHETER
• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13121742
• MDR Text Key: 286884782
• Report Number: 2029046-2021-02278
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2021
• Device Catalogue Number: D139001
• Device Lot Number: 30479514L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK_HELIOSTAR CATHETER