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

Model Number D132705

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good condition, however, during the second visual inspection the t bar metal was observed exposed on the tip area.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.Customer complaint was confirmed.The t bar slippage and the t bar exposed could be related to the usage of the device, however this cannot be conclusively determined.In addition, there was a previous investigation to reduce the t bar slippage failure mode.(b)(4).

Event Description

It was reported that a patient underwent an paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter for which biosense webster¿s product analysis lab has identified the t-bar metal was exposed on the tip of the catheter.It was initially reported by the customer that after one (1) hour of procedure, one of the two (2) curvature springs broke.They physician was not able to perform ablation with the defective device.There is no information on how the issue was resolved, however, there were no patient consequences and the procedure was successfully completed.The customer¿s reported deflection issue was assessed as not mdr reportable since the most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On 12/22/2019, the bwi product analysis lab received the device for evaluation.Initial visual analysis observed there was no visual physical damage.On 1/3/2020, during a second visual analysis, it was found that the t-bar metal was exposed as the catheter tip.This finding was reviewed and determined to be an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 1/3/2020 and reassessed the complaint as mdr reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 9641836
• MDR Text Key: 200079528
• Report Number: 2029046-2020-00142
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/13/2019

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: 08/08/2020
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30270201M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1