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

Catalog Number D133604IL

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was inspected and distal tip appears to be pinched creating a dent.Then, during the second visual was confirmed distal tip pinched creating a dent, electrode #04 lifted and peek housing damage.Per the customer¿s reported issue, the catheter was tested for deflection and the catheter failed.Afterwards, an x-ray of the catheter was taken and it was noticed that the t-bar slipped down from it¿s place.The root cause of the peek housing damage could be related to the t-bar slipping down.A manufacturing record evaluation was performed and no internal actions related to the complaint was found during the review.The customer complaint was confirmed.The root cause of electrode #04 lifted 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.The root cause of the t-bar slip cannot be determined.(b)(6).Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab has identified damage on electrode #04 (lifted) and peek housing damage.It was initially reported by the customer that during the procedure the catheter could not deflect to the specification.A second catheter was used to complete the operation.There were no patience consequences.The customer¿s reported issue is not mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 10/16/2019, the complaint device was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found the distal tip which appeared to be pinched creating a dent, however, this finding was not considered to be mdr reportable.On 11/5/2019, during a second visual analysis, electrode #04 was found lifted and the peek housing damaged.These findings were reviewed and determined the lifted electrode is an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 11/5/2019 and reassessed this complaint as mdr reportable.

• 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
• 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: 9401878
• MDR Text Key: 195390921
• Report Number: 2029046-2019-03947
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30209847M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1