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 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 01-nov-2022.The device evaluation was completed on 08-nov-2022.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax.A sem (scanning electron microscope) study was performed and mechanical damage and a hole was observed on the pebax surface.However, it was determined that this issue is unrelated to the event described by the customer.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 batch number, and no internal actions were identified.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).The ¿suspected medical device¿ reported in this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # p030031/s053.Manufacturer's reference number: (b)(4).

Event Description

Hold dm 1.19.23 log.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter and a biosense webster, inc.Product analysis lab observed a hole on the pebax surface.Initially a deflection issue was reported.During the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on the patient.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 08-nov-2022 there was a visual analysis which revealed reddish material inside the pebax.A sem (scanning electron microscope) study was performed, and mechanical damage and a hole was observed on the pebax surface.The hole on the pebax surface was assessed as mdr reportable.The awareness date for this reportable lab finding was 08-nov-2022.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15937821
• MDR Text Key: 307825264
• Report Number: 2029046-2022-03052
• 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: 12/07/2022

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: 03/30/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30760268M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER.