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

Catalog Number D133604IL

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

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(s) 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.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and an issue of ¿deflection was inadequate¿ occurred.During the operation, the catheter could not deflect to specification.The second catheter was used to complete the operation.There was no report on patient injury.There was no patient consequence.The issue of inadequate deflection is not a reportable event.The complaint product was returned to biosense webster inc.¿s (bwi) failure analysis lab (fal) for evaluation.During analysis the catheter tip was found dented and peebax was found broken.A hole on the pebax is considered a reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction on (b)(6) 2018 and has reassessed this complaint as reportable.

Manufacturer Narrative

It was reported that during the operation, the catheter could not deflect to specification.Upon return to bwi¿s failure analysis lab for evaluation, the catheter tip was found dented and peebax was found broken.A hole on the pebax is considered a reportable malfunction.Product evaluation summary: the device was visually inspected and the tip was found dented and the pebax broken.Then, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage, stress marks and holes on the surface of the pebax, dome also showed mechanical damage with a partially occluded irrigation hole caused by the same damage 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 cannot be confirmed.The root cause of the damage on the tip and 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¿ 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: 7642285
• MDR Text Key: 112893555
• Report Number: 2029046-2018-01738
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/19/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30007273M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1