MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab found the returned condition of the polyurethane (pu) peeling.Initially, it was reported that during the procedure, the temperature displayed high which lead to the catheter would not discharge.A second catheter was used to complete the procedure.There was no patient consequence reported.The temperature issue was assessed as not mdr 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 on december 23, 2019 and noted that the polyurethane (pu) was peeling on the proximal side of ring #1.This returned condition was assessed as a reportable issue.The awareness date for this reportable lab finding is december 23, 2019.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter.It was reported that during the procedure, the temperature displayed high which lead to the catheter would not discharge.A second catheter was used to complete the procedure.There was no patient consequence reported.The returned device was visually inspected and it was found that the polyurethane (pu) was peeling on ring #1.Then, an electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.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 the catheter was not irrigating correctly as no irrigation was observed when the catheter was deflected.The irrigation tube was found bent.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the irrigation tube bent and electrode damaged 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 procedure; however, this cannot be conclusively determined.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¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9604956
• MDR Text Key: 200075872
• Report Number: 2029046-2020-00109
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30236045M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1