MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSOSTAR CIRCULAR MAPPING CATHETER; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number UNK_LASSOSTAR CATHETER

Device Problem Material Separation (1562)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

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 803.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 a paroxysmal atrial fibrillation (afib) procedure with a lassostar circular mapping catheter and a catheter shaft detached/broken inside the patient issue occurred.Initially it was reported that the heliostar internal lumen occluded.The procedure was not delayed due to the reported event.The procedure was completed successfully.No patient consequence was reported.Additional information was received on 12-may-2023.The interior of the heliostar was narrow.Its interior did not allow the lassostar circular mapping catheter to pass through it.The lassostar circular mapping catheter broke (kneed and broke the magnetic sensor) trying to pass inside the heliostar.No photo¿s were available.This event was originally considered non-reportable, however, bwi became aware of the lassostar circular mapping catheter broke (kneed and broke the magnetic sensor) on 12-may-2023 and have reassessed the event as reportable for a catheter shaft detached/broken inside the patient issue.

Manufacturer Narrative

The investigation was completed on 06-jun-2023.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 CIRCULAR MAPPING CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: 17060276
• MDR Text Key: 316627150
• Report Number: 2029046-2023-01218
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LASSOSTAR CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 10.5FR 28MM BALLOON ABLAT CATH