MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NI75TCDH

Device Problem Positioning Problem (3009)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a crack on the pebax.It was initially reported by the customer that during the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete.There was no adverse event reported on patient.The customer¿s reported deflection issue is not considered to be mdr reportable since the most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found the peek housing was found cracked with exposed wires.This finding was reviewed and assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed the peek housing was found cracked with exposed wires.The damage could be related to excessive force or to the shipment process.A follow up was made to clarify if this condition was observed during the procedure.Multiple attempts have been made to obtain the above information.However, no additional information has been received.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device number and no internal action related to the complaint were found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: membrane (g04088) were selected as related to the crack/hole identified by the bwi pal.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported deflection issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 16415001
• MDR Text Key: 310330978
• Report Number: 2029046-2023-00338
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: 10846835000559
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031
• 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
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30831266M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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: DEF 7.5F,TCNSTC,4P,D,252MM,HYP