MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Crack (1135); Material Puncture/Hole (1504); Failure to Sense (1559)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 05-mar-2022.The device evaluation was completed on 22-apr-2022.The device was returned to biosense webster for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed the peek housing cracked with internal parts exposed and a hole on pebax.A screening test was performed and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit on the tip area.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed the pebax with a hole and the peek housing cracked with the internal parts exposed.Initially it was reported that the thermocool® smart touch® sf bi-directional navigation catheter was connected and an error 106 occurred.It occurred after initializing and before inserting into the patient¿s body.The cable was changed but the issue continued.The issue was resolved by changing the thermocool® smart touch® sf bi-directional navigation catheter to another one.The procedure was completed without patient's consequence.The force sensor error 106 was assessed as not mdr reportable as the warning functioned as intended.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 22-apr-2022, they observed the issues of the peek housing cracked with internal parts exposed and a hole on pebax.The returned conditions of the pebax with the hole and the peek housing cracked with the internal parts exposed were both assessed as mdr reportable issues.The awareness date for these reportable lab findings were 22-apr-2022.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 14432450
• MDR Text Key: 295813773
• Report Number: 2029046-2022-01047
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30661451L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2022
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• 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 CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER