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 Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The investigational analysis has been completed.The device was inspected, and it was found that shaft was separated from the handle.Due to return conditions, catheter could not be analyzed.A manufacturing record evaluation was performed and no non-conformances related to the complaint was found during the review.The customer complaint could not be confirmed.The root cause of the damage on shaft cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the shipment, however, this cannot be conclusively determined.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for premature ventricular contraction (pvc) with a navi-star¿ thermo-cool¿ electrophysiology catheter wherein device entrapment occurred.During the pvc operation, a deflection issue was reported.The handle of the catheter rotated a circle but the tip of the catheter could not rotate a circle at the same time.A second catheter was used to complete the operation.On 10/19/2020, biosense webster inc.Received additional information indicating the physician found the catheter impeded in the sheath and it couldn't be withdrawn.The operation was changed to a surgical procedure.The surgeon cut off the catheter and placed another sheath; used one capture device to pull back the rest of the catheter.The operation was delayed about two hours.After evaluation of the additional information, the event was adjusted as product malfunction.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.This event was originally considered non-reportable, however, bwi became aware of additional information on 10/19/2020 reporting a product malfunction.

• 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.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10857416
• MDR Text Key: 247898214
• Report Number: 2029046-2020-01752
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2020

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: 01/23/2023
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30334996M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/17/2020
• Date Device Manufactured: 01/24/2020
• 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