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 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.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.Manufacturer's reference # (b)(4).

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 the biosense webster, inc.Product analysis lab identified that both the peek housing and sensor were cracked open with internal wiring exposed.Initially it was reported that during the premature ventricular contraction (pvc) procedure, error 106, magnetic sensor error was displayed.The catheter was replaced with another and the procedure was completed.There was no patient consequence reported.The magnetic sensor error 106 was assessed as not reportable.The potential risk that it could cause or contribute to a serious injury or death was remote.On january 6, 2020, the biosense webster, inc.Product analysis lab received the device for evaluation, and upon initial visual inspection, it was observed that the peek housing was cracked with exposed parts.The issue of peek housing cracked with exposed parts was assessed as a reportable event.This event was originally considered not mdr reportable, however, biosense webster, inc.Became aware of a reportable malfunction upon receipt of the device on january 6, 2020 and have reassessed this complaint as reportable.Therefore, the awareness date for this reportable lab finding is january 6, 2020.

Manufacturer Narrative

Additional information was received from the customer on 2/9/2020 and it was noted that no damage was observed before, after or during procedure.The condition that the device was received in may have occurred during the shipping process, as it was shipped in good condition.Based on this information, this finding was re-assessed as not reportable.Investigation summary: it was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter for which the biosense webster, inc.Product analysis lab identified that both the peek housing and sensor were cracked open with internal wiring exposed.Initially it was reported that during the premature ventricular contraction (pvc) procedure, error 106, magnetic sensor error was displayed.The catheter was replaced with another and the procedure was completed.There was no patient consequence reported.The device was visually inspected, and it was that both the peek housing and sensor were found to be cracked open with internal wiring exposed.The magnetic sensor functionality testing could not be tested due to returned condition.A manufacturing record evaluation was performed for the finished device number 30256369m, and no internal actions related to the reported complaint was found during the review.The customer complaint cannot be confirmed.The root cause of the damage on 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 shipping; however, this cannot be conclusively determined.Manufacturer's reference # (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: 9662439
• MDR Text Key: 194824832
• Report Number: 2029046-2020-00156
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30256369M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 02/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1