MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Insufficient Cooling (1130); Material Split, Cut or Torn (4008)

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

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(4) 2020.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed internal parts exposed on the shaft.Initially it was reported that while ablating, the ablation signal was not going away.The ablation power was set at 50 watts.The catheter irrigation was checked to ensure it was working.No errors displayed.The temperature cut off was not exceeded.The catheter was replaced and the issue resolved.The grounding pad was replaced as well and the physician was then satisfied with the ablating with the second catheter.The procedure continued.There was no patient consequence reported.The temperature issue was assessed as not mdr reportable.Since the user cut-off was not exceeded 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 observed on 12/15/2020 internal parts exposed on the shaft near the tip transition.This returned condition was assessed as a mdr reportable malfunction.The awareness date for this lab finding is 121/15/2020.

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2020.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.Initially it was reported that while ablating, the ablation signal was not going away.The ablation power was set at 50 watts.The catheter irrigation was checked to ensure it was working.No errors displayed.The temperature cut off was not exceeded.The catheter was replaced and the issue resolved.The grounding pad was replaced as well and the physician was then satisfied with the ablating with the second catheter.The procedure continued.There was no patient consequence reported.The device was visually inspected and it was found with internal parts exposed on the shaft near the tip transition.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, a cool flow pump test was performed and it was found within specifications.The catheter was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The customer complaint cannot be confirmed.The root cause of the internal parts exposed cannot be related to the manufacturing process since there was 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 procedure; however, this cannot be conclusively determined.The root cause of the high temperature issue remains unknown as no device problem found/no problem detected.The investigation conclusions code of ¿cause not established" , investigation findings code of ¿mechanical problem identified¿ and component code of ¿catheter¿ is related to the internal parts exposed issue observed during the evaluation of the device.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11164486
• MDR Text Key: 231952332
• Report Number: 2029046-2021-00041
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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: 08/12/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30420069M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND GENERATOR