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 08/14/2022

Event Type  malfunction  

Manufacturer Narrative

The ¿suspected medical device¿ reported 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.The bwi product analysis lab received the device for evaluation on 07-oct-2022.The investigation was completed on 14-oct-2022.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip of the catheter was observed slightly deflected; however, the piston is not completely up.The customer complaint was not confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.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 a peek housing cracked with exposed internal wires.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The root cause of peek housing cracked broken could be related to the shipping process; however, it cannot be determined.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.A manufacturing record evaluation was performed for the finished device 30776523m number, and no internal action was found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.-investigation findings: no device problem found / investigation conclusions: no problem detected were selected as related to the customer¿s reported ¿deflection issues¿.-investigation findings: mechanical problem identified / investigation conclusions: cause not established / (b)(4).-investigation findings: appropriate term/code not available / investigation conclusions: cause not established were selected as related to the analysis for the picture received by the customer.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab observed the peek housing cracked with internal wires exposed.Initially, 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 event was assessed as not mdr for a deflection issue.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 14-oct-2022, the peek housing was observed cracked with internal wires exposed.Multiple attempts have been made to obtain clarification to the returned condition; however, no further information has been made available.The peek housing cracked with internal wires exposed was assessed as mdr reportable.The awareness date for this reportable lab finding was 14-oct-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: 15775614
• MDR Text Key: 307932911
• Report Number: 2029046-2022-02800
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30776523M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• 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