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

Catalog Number D139001

Device Problems Signal Artifact/Noise (1036); Material Separation (1562)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a lassostar, 10p, dia 15mm loop size.The catheter outer layer/insulation had broken.During the procedure, the team noticed the visualization of the catheter on the carto became intermittent with noise on poles 7-10.The operator withdrew the catheter and noticed the catheter outer layer/insulation had broken.The catheter was replaced with another lassostar to continue the case.There was no patient impact and the procedure was not extended greater than 30 minutes due to the failure.This was part of the heliostar ee clinical study.The noise issue was assessed as not mdr reportable as the risk to the patient was low.The catheter outer layer/insulation had broken was assessed as mdr reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 26-aug-2022.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 23-sep-2022.It was reported that a patient underwent an ablation procedure with a lassostar, 10p, dia 15mm loop size.During the procedure, the team noticed the visualization of the catheter on the carto became intermittent with noise on poles 7-10.The operator withdrew the catheter and noticed the catheter outer layer/insulation had broken.The catheter was replaced with another lassostar to continue the case.There was no patient impact and the procedure was not extended greater than 30 minutes due to the failure.This was part of the heliostar ee clinical study.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 broken with internal parts exposed.An electrical test was performed.However, during the test, intermittence was noticed; this could be related to the shaft broken.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 internal actions were identified.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 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: 15180654
• MDR Text Key: 304724832
• Report Number: 2029046-2022-01802
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2022

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: 11/18/2022
• Device Catalogue Number: D139001
• Device Lot Number: 30687371L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/07/2022
• Supplement Dates Manufacturer Received: 08/26/2022; 09/23/2022
• Supplement Dates FDA Received: 08/29/2022; 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• 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: UNK_CARTO 3; UNK_LASSOSTAR CATHETER