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

Catalog Number D140402

Device Problem Material Separation (1562)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a lassostar nav circular mapping catheter and a ripped catheter issue occurred.During insertion of the lassostar into the y-connector, the lassostar got stuck after about 3cm.When pulling the lassostar out, it ripped.A new y-connector and a new lassostar we¿re needed.The surgery was delayed by five minutes.Additional information was received on 03-aug-2023.It ripped while trying to introduce into the heliostar.There was visible damage on the shaft of the catheter.There is no picture available.There was no patient consequence.

Manufacturer Narrative

B3.Date of event: the event date is unknown.As a result, the 1st day of the year has been entered as the event date.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).

Manufacturer Narrative

Initially, it was reported that a patient underwent a cardiac ablation procedure with a lassostar nav circular mapping catheter and a ripped catheter issue occurred.During insertion of the lassostar into the y-connector, the lassostar got stuck after about 3cm.When pulling the lassostar out, it ripped.A new y-connector and a new lassostar we¿re needed.The surgery was delayed by five minutes.The ripped catheter issue remains assessed as mdr reportable.The additional finding of the broken shaft was also assessed as mdr reportable.The awareness date is 23-oct-2023.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation on 17-oct-2023.A visual inspection was performed following bwi procedures.Visual analysis revealed that the catheter shaft was observed broken, leaving internal components exposed.The damage observed could have been caused during removal of the catheter after the procedure, or the manipulation of the catheter during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device number lot 30954747l and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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 NAV CIRCULAR MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 17599819
• MDR Text Key: 321729076
• Report Number: 2029046-2023-01833
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835020342
• UDI-Public: 10846835020342
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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: 11/08/2023
• Device Catalogue Number: D140402
• Device Lot Number: 30954747L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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.