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

Catalog Number D133604IL

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

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.Manufacture reference no (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and during ablation a kink was observed.A second catheter was used to complete the operation.No adverse patient consequences were reported.The issue of the kink in the catheter is not reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.The bwi failure analysis lab (fal) received the device for evaluation on (b)(6) 2018.The (b)(6) 2018 fal findings were exposed wire 3.8cm to 5.2cm from distal tip and electrode damage.This finding has been assessed as reportable.The awareness date was reset to (b)(6) 2018.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and during ablation a kink was observed.The investigational analysis completed on 11/12/2018.The device was inspected.Although no kink was found, an exposed wire in the tip and sharp edges on a ring were observed.The catheter was observed under the x ray machine and the t bars were observed in the correct position.Scanning electron microscope (sem) analysis was performed on the damaged area.The results showed that the tip lumen showed the same wall size and the tip lumen was within specifications.No anomalies were observed.The manufacture team performed an investigation to find the root cause.The investigation results showed that this issue is not related to the manufacturing process.There is evidence to assure that the manufacturing process for flexible tip assembly is of quality and integrity as the process was executed multiple times and the failure mode was unable to be duplicated.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 not confirmed.The root cause of the puller wire exposed cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacture ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and during ablation a kink was observed.During additional device assessment by the bwi failure analysis lab (fal), it was discovered on 9/28/2018 that there were sharp edges on damaged ring for puller wire.This additional finding has been assessed as reportable.The awareness date was reset to 9/28/2018.On 10/17/2018, information was provided indicating that the device history record (dhr) for the lot number 30017232m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer ref no: (b)(4).

• 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: 7919899
• MDR Text Key: 123533104
• Report Number: 2029046-2018-02123
• 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,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30017232M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1