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 Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation on december 23, 2019.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab discovered the peek housing slit with exposed parts.Initially during the procedure, the impedance was displayed high; therefore, the catheter could not discharge.A second catheter was used to complete the procedure.There was no patient consequence reported.The high impedance issue was assessed as not reportable.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and noted on december 23, 2019 that the peek housing was slit in half between ring 1 and 2 exposing internal wires.The distal tip appeared bent out of shape.This returned condition was assessed as reportable.The awareness date for this reportable lab finding is december 23, 2019.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter.During the procedure, the impedance was displayed high; therefore, the catheter could not discharge.A second catheter was used to complete the procedure.There was no patient consequence reported.An analysis was performed on the pictures that were provided by the customer.According to the pictures, high impedance was observed on the generator screen.The customer complaint was confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.The returned device was visually inspected and it was found that the peek housing was slit in half between ring #1 and #2 exposing internal wires.The distal tip appeared bent out of shape.The returned device was then evaluated for electrical resistance and current leakage and it failed on electrodes # 1 and # 2.Further examination revealed that the lead wires #1 and #2 were broken causing the improper signal condition.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding impedance has been confirmed.The root cause of wires broken, bent tip and damage on the peek housing 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.Per the picture analysis, the screen shot provided that a generator was being used in the procedure.Therefore, added to "d11.Concomitant medical products and therapy dates" "unknown brand generator." if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (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; 33 technology drive; irvine CA 92618
• MDR Report Key: 9607829
• MDR Text Key: 200478201
• Report Number: 2029046-2020-00111
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: 10846835000559
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30216429M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND GENERATOR