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 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

The event date is unknown.Therefore, the (b)(6) has been entered as the event date under date of event.The bwi product analysis lab received the device for evaluation 12-apr-2022.The device evaluation was completed on 15-jun-2022.The 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 area near the connector was damaged leaving some internal parts exposed.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: if a lassostar¿ catheter is used with the heliostar¿ catheter, do not extend the heliostar¿ catheter beyond the sheath tip until the lassostar¿ catheter has been fully advanced out of the guidewire lumen.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.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 damage on the shaft leaving internal parts exposed.Initially it was reported that the shaft was kinked during insertion into the heliostar.A new lassostar was necessary.There were no patient consequences reported.Additional information was received on the event.The damage did not result in wires/internal components being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The oscor,guidestar 13.5f sheath was used.The event was assessed as not mdr reportable for a 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 15-jun-2022, the shaft area near the connector was damaged leaving some internal parts exposed.The damage on the shaft leaving internal parts exposed was assessed as mdr reportable for a ¿broken shaft (mid shaft)¿ issue.The awareness date for this reportable lab finding was 15-jun-2022.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14952840
• MDR Text Key: 304435956
• Report Number: 2029046-2022-01551
• 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: 07/07/2022

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: 08/31/2022
• Device Catalogue Number: D139001
• Device Lot Number: 30633520L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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: NON BWI- OSCOR,GUIDESTAR 13.5F SHEATH; UNK_HELIOSTAR CATHETER; UNK_LASSOSTAR CATHETER