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

Catalog Number D133604IL

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The returned device was visually inspected and it was found in normal conditions.Second visual analysis was performed and it was found kink was found in the peek housing.A crack was found in the tip-shaft transition, metal exposed.Then, a deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was observed under the x ray machine and the t bar was found slid down causing the improper deflection condition.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint has been verified.The root cause of the catheter t-bar displacement, kink and broken tip 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 slippage cannot be determined, however, an internal corrective action has been opened to investigate the issue of the t bar sliding down.(b)(6).Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab has identified a crack in the material with internal metal components exposed.It was initially reported by the customer that during the afib operation, the thermocool® smart touch¿ electrophysiology catheter could not deflect (or curve) to the desired specification.A second catheter was used to complete the operation.There was no patient consequence.The customer¿s reported ¿deflection¿ issue is not mdr reportable since there is evidence of a product malfunction, however the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 8/27/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found there was no visual damage or anomalies.On 9/13/2019, during a second visual analysis, a kink was observed in the peek housing area and a crack was found at the tip of the shaft transition with internal metals exposed.The findings were reviewed and determined to be mdr reportable as a malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 9/13/2019 and have reassessed this complaint as 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: 9210214
• MDR Text Key: 195043154
• Report Number: 2029046-2019-03739
• 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: 08/12/2019

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: 03/10/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30188184M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2019
• 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