MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMARTTOUCH,TC,D,C3,OBL; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.Product 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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found electrode #4 lifted, exposing external parts.Initially, it was reported that during ablation the catheter had much interference.The catheter was replaced and a second catheter was used to complete the operation.No adverse patient consequences were reported.The observed noise has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The bwi pal received the device for evaluation on 12/2/2019.Upon initial inspection, the distal tip was observed bent and kinked about 26 cm from distal tip.The observed bent tip has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Further testing was performed.During a second visual inspection on 12/19/2019, the bwi pal found a kink in the shaft and a dent in the peek housing.The kinked shaft and dented peek housing has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Additionally, electrode #4 lifted, exposing internal parts.The observed lifted electrode has been assessed as mdr reportable.The awareness date has been reset to 12/19/2019.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found electrode #4 lifted, exposing external parts.Initially, it was reported that during ablation the catheter had much interference.The investigational analysis was completed 1/24/2020.The device was visually inspected and a kink in the shaft was found.During a second inspection, peek housing was found dented, and electrode #4 was found lifted with a dent and no polyurethane.Then, electrical testing was performed and the catheter failed.No electrical readings were observed on electrodes.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.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of the electrical wire breakage cannot be determined.The root cause of the damage on electrode 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.Manufacture reference no: (b)(4).

• Brand Name: THMCL SMARTTOUCH,TC,D,C3,OBL
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9589478
• MDR Text Key: 200067121
• Report Number: 2029046-2020-00094
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 11/11/2019

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: 05/23/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30226294M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1