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

Catalog Number D134805

Device Problems Loss of or Failure to Bond (1068); Split (2537); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure 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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent a ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the smart touch sf catheter could not be deflected as intended.There was no patient consequence.When the catheter was replaced, the issue was resolved.This event was originally assessed as not mdr reportable because the potential risk that it could cause or contribute to a serious injury or death is remote.The device was returned to the biosense webster failure analysis lab for analysis, and on april 6, 2018 and after visual inspection, it was found that the transition between the tip section and the shaft was exposed.The polyurethane was not covering the transition and the internal wires and tubings were exposed.It is possible that the damage was generated with an unknown object and/or excessive manipulation.This finding has been assessed as a reportable malfunction.The awareness date has been reset to april 6, 2018.

Manufacturer Narrative

It was reported that a patient underwent a ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the smart touch sf catheter could not be deflected as intended.The device was visually inspected and the peek housing was found cracked with metal exposed which made this complaint reportable.Then, deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was dissected on the tip area, the t-bar was found slid down causing the improper deflection condition, also, residues of polyurethane application was found at the t-bar anchored place which indicates a proper manufacturing assembly.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.On line, functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed.The root cause of the t-bar slippage cannot be determined, however,an internal corrective action was created to investigate this issue, the root cause of the peek housing cracked is related to the t-bar slid down issue.Manufacturer's ref.No: (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: 7477971
• MDR Text Key: 107699379
• Report Number: 2029046-2018-01495
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17740123L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1