MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

The bwi 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.On 6/6/2019, a manufacturing record evaluation was performed for the finished device and no internal actions were identified.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a slit in the shaft, exposing internal components.Initially, it was reported during an afib ablation procedure the catheter could not deflect to specification.A second catheter was used to complete the operation.No adverse patient consequences were reported.The observed deflection issue 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.On 5/29/2019, the bwi pal received the device for evaluation.Upon initial inspection, no damage or anomalies were observed.During decontamination on 5/30/2019, a slit was found in the shaft; approximately 38 cm from the distal tip; exposing wires.The observed slit has been assessed as a reportable as device integrity was compromised.The awareness date has been reset to 5/30/2019.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a slit in the shaft, exposing internal components.Initially, it was reported during an afib ablation procedure the catheter could not deflect to specification.During an internal review, it was noticed that device evaluation was omitted from the initial report in error.The investigation completed (b)(6) 2019.The device was visually inspected, and the shaft was found damaged with internal braid wiring exposed.Deflection testing was performed, and it was found within specifications.The catheter was deflecting correctly.A manufacturing record evaluation was performed, and no internal actions were identified.The customer complaint cannot be confirmed.The root cause of the shaft damage with exposed wires 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.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8731708
• MDR Text Key: 150172927
• Report Number: 2029046-2019-03320
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30146243M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1