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

Catalog Number D139001

Device Problems Material Too Rigid or Stiff (1544); Material Split, Cut or Torn (4008)

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

Event Date 03/03/2022

Event Type  malfunction  

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 the shaft broken with internal parts exposed.Initially, it was reported that there was a product defect.After unpacking the lassostar, 10p, dia 15mm loop size, damage was found.The catheter wire was broken.A new catheter was required.No patient consequence was reported.Additional information received stated that the puller wire was broken.The event was assessed as not mdr reportable for a catheter stiffness deflection mechanism issue.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2022 found the shaft broken with internal parts exposed.The shaft broken with internal parts exposed was assessed as mdr reportable for a broken shaft (mid shaft).The awareness date for this reportable lab finding was (b)(6) 2022.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2022.The device evaluation was completed on (b)(6) 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 was damaged in the middle section leaving some internal parts exposed.A manufacturing record evaluation was performed for the finished device 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.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: LASSOSTAR,10P, DIA 15MM LOOP
• 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: 14784379
• MDR Text Key: 297162556
• Report Number: 2029046-2022-01409
• 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: 06/22/2022

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: 30638524L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/23/2022
• 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: UNKNOWN BRAND CATHETER