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

Model Number D134805

Device Problem Failure to Sense (1559)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the biosense webster inc, (bwi) product analysis lab observed a reddish-brown material inside and a hole in the pebax of the device with internal parts exposed.Initially, it was reported that immediately after use of the catheter, an error code 105 was displayed.The cable was changed but the issue continued.The issue was resolved by changing the smart touch sf catheter to another one.The procedure was completed without patient consequence.The magnetic sensor error issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found reddish-brown material inside and a hole in the pebax of the device with internal parts exposed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 16-nov-2022.

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.(bwi) product analysis lab received the device on 17-oct-2022.The device evaluation was completed on 16-nov-2022.Bwi conducted a visual inspection and magnetic sensor functionality test of the returned catheter.Visual analysis of the returned catheter revealed reddish-brown material inside and a hole in the pebax of the device with internal parts exposed.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues were observed.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 30837173l number, and no internal actions related to the complaint were found during the review.The magnetic sensor error described was unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15984558
• MDR Text Key: 308212399
• Report Number: 2029046-2022-03128
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2022

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30837173L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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: UNK BRAND CABLE; UNK BRAND CABLE; UNK_SMART TOUCH BIDIRECTIONAL SF