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

Catalog Number D134805

Device Problems Device Contamination with Chemical or Other Material (2944); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed on (b)(4) 2018.The device was inspected and ring #1 was found sharp and with white plastic like material underneath it.Electrical testing was performed and the catheter failed.No electrical readings were observed on ring # 1.A failure analysis was performed and the catheter was dissected on the tip area.The electrical wire was found broken causing the improper electrical signal.The catheter outer diameter was measured and it was found within specification.Only the ring # 1 failed due to the damage observed.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that white particle is primarily composed of a polyethylene-based material with second component a barium sulfate.The composite material is widely used along medical device industries.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 the manufacturing process, inspections and functional tests are in place to prevent this type of failure from leaving the facility.Manufacturer ref no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, and a no signal in distal electrode issue occurred.No adverse patient consequences were reported.The no signal in distal electrode issue has been assessed as not reportable.The biosense webster inc.(bw)i failure analysis lab (fal) received the device for evaluation on (b)(4) 2018 and it was discovered that ring #1 proximal side is sharp with white plastic like material underneath it.The sharp edges and foreign material issue has been assessed as reportable.The awareness date has been reset to (b)(4) 2018.

Manufacturer Narrative

A portion of the previously submitted device evaluation was omitted in error.The correct device evaluation is below.The investigational analysis completed on (b)(6) 2018.The device was inspected and ring #1 was found sharp and with white plastic like material underneath it.Electrical testing was performed and the catheter failed.No electrical readings were observed on ring # 1.A failure analysis was performed and the catheter was dissected on the tip area.The electrical wire was found broken causing the improper electrical signal.The catheter outer diameter was measured and it was found within specification.Only the ring # 1 failed due to the damage observed.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that white particle is primarily composed of a polyethylene-based material with second component a barium sulfate.The composite material is widely used along medical device industries.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 the manufacturing process, inspections and 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 electrical wire breakage cannot be determined.It could be related to the damage on the ring.However, this cannot be conclusively determined.Based on the fourier transform infra red analysis (ftir) results, the root cause of the ring damage and the foreign material underneath it could be related to the manipulation between the catheter and the sheath used during the procedure.Manufacturer 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 92618
• MDR Report Key: 8049285
• MDR Text Key: 128739256
• Report Number: 2029046-2018-02252
• 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: 10/01/2018

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: No Information
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30026981L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1