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

Catalog Number D133604IL

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the device was inspected, and it was found in normal conditions, then, during the second visual inspection, the pebax was found damage and the peek housing tip transition was found cracked with no internal parts exposed.Then, electrical test was performed, and the catheter failed, no electrical readings were observed on electrode # 1 and # 2.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.Then, deflection test was performed, and the catheter failed.A failure analysis was performed, and the catheter was observed under the x ray machine and the t bar was found slid down causing the improper deflection condition.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the electrical issue cannot be determined; however, an internal action was created to investigate this issue.The root cause of the t bar slippage cannot be determined; however, an internal action was created to investigate this issue.The root cause of the peek housing cracked is related to the t bar slippage issue.The root cause of the damage on pebax 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.Manufacturer's reference #: (b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) procedure with a thermocool® smart touch¿ electrophysiology catheter and it was reported that the pebax was found with damage, crack was observed in the peek housing transition, and internal parts exposed.Initially it was reported that there was no impedance being displayed.The catheter was replaced, and the issue resolved.The procedure was completed successfully.There was no patient consequence.The issue of no impedance was assessed as a not reportable event.The biosense webster, inc.Product analysis lab received the device for evaluation on april 4, 2019 and it was reported that the pebax was found with damage, crack was observed in the peek housing transition, and internal parts exposed.The issue of pebax cracked/broken was assessed as a reportable event.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8579384
• MDR Text Key: 145964266
• Report Number: 2029046-2019-03063
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2019

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: 09/02/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30104079M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1