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

Catalog Number D133604IL

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab observed the peek housing cracked with exposed parts.Initially, it was reported that there was a deflection issue.During the procedure, the catheter was unable to deflect or relax completely.A second catheter was used to complete the procedure.There was no patient consequence reported.The deflection issue was assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 18-jul-2022, it was observed that there was a broken peek housing with metal exposed.Additional request was sent for clarification on this returned condition.However, no further information has been made available.The broken peek housing with metal exposed was assessed as mdr reportable for a peek housing cracked with exposed parts.The awareness date for this reportable lab finding was 18-jul-2022.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 11-apr-2022.The device evaluation was completed on 18-jul-2022.The device was returned to biosense webster for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis of the returned device revealed a broken peek housing with metal exposed was observed on the returned device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.(b)(4).Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15215358
• MDR Text Key: 304989947
• Report Number: 2029046-2022-01858
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Catalogue Number: D133604IL
• Device Lot Number: 30647428M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Treatment: UNKNOWN BRAND CATHETER