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

Model Number	D140401
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: initial reporter phone: (b)(6).The event date is unknown.As a result, the 1st day of the year has been entered as the event date under date of event.Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30788644l number, and no internal actions related to the complaint was found during the review.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 or Problem Description
It was reported that a patient underwent a procedure with a lassostar nav and a catheter shaft detached/broken inside the patient issue occurred.The lassostar nav catheter was already inserted into the balloon and had to be pulled out to insert it into the new balloon.Unfortunately, it broke during this process and was exchanged for a new catheter of the same type.The procedure was successfully completed by using another technology (pfa) from another company without any consequences for the patient.Total troubleshooting delay was 25 minutes.Additional information was received.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.When the new lassostarnav catheter was inserted into the new heliostar balloon, it was not possible to push it forward, because there was resistance inside the handle of the balloon.There are no pictures available.The issue was approximately 30cm from tip.The catheter was not pre-shaped.The shaft got broken.The event was assessed as mdr reportable for the catheter shaft detached/broken inside the patient issue.

• Brand Name: LASSOSTAR NAV CIRCULAR MAPPING CATHETER
• Common Device Name: 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: 16591212
• Report Number: 2029046-2023-00597
• Device Sequence Number: 4947601
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2023
• Device Model Number: D140401
• Device Catalogue Number: D140401
• Device Lot Number: 30788644L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.5FR 28MM BALLOON ABLAT CATH; 10.5FR 28MM BALLOON ABLAT CATH; 10.5FR 28MM BALLOON ABLAT CATH; LASSOSTARNAV CATHETER; NGEN PUMP, EU CONFIGURATION; NGEN RF GENERATOR; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE
• Patient Sex: Unknown