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

Catalog Number D134805

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

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) has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s ref #: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the contact force value of the catheter was displayed as hi.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.This issue was assessed as not reportable.The complaint product was returned to biosense webster inc.¿s (bwi) failure analysis lab (fal) for evaluation.During evaluation on 5/24/2018, scanning electron microscope (sem) test results showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.A hole on the pebax is considered a reportable malfunction.This complaint was originally considered non-reportable, however, bwi became aware of a reportable malfunction through sem analysis on 05/24/2018 and has reassessed this complaint as reportable.

Manufacturer Narrative

A patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the contact force value of the catheter was displayed as hi.Additionally, failure analysis lab (fal) initial evaluation of the returned product identified mechanical damage, stress marks and a hole on the surface of the pebax.A hole on the pebax is considered a reportable malfunction.Product evaluation details: the device was visually inspected and the reddish residue was found inside the pebax, no damage was observed.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, during the force test, high values were observed, for this condition, the accuracy test was performed and the catheter passed, this could related to an electrical intermittent on the force sensor.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.No other anomalies were observed.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of the damage on the pebax cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s ref # (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: 7626515
• MDR Text Key: 112501691
• Report Number: 2029046-2018-01721
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17752588L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1