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

Model Number D134805

Device Problems High Readings (2459); Material Split, Cut or Torn (4008)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 09-apr-2022.The device evaluation was completed on 29-apr-2022.The device was returned to bwi for evaluation.Bwi conducted a visual inspection and failure analysis on the returned device.Visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue.Then the catheter was connected to the carto 3 system and was recognized and the hi error was visualized.For this finding, the test was unable to be performed.The evaluation determined that the cause of pebax damage failure cannot be established.However, the blood found inside the pebax area may have contributed to the hi error displayed on the carto 3 system.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: -for force issues, the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a cut on the pebax with internal parts exposed.Initially it was reported that the carto 3 system had high force readings upon ablation starting.The catheter cable was replaced and the issue did not resolve.The catheter was replaced and the issue resolved.Case continued.There was no patient consequence reported.The high force issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 29-apr-2022 there was a cut on the pebax with reddish-brown material inside and internal parts exposed.The cut on the pebax with internal parts exposed was assessed as mdr reportable.The awareness date for this reportable lab finding was 29-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: 14466049
• MDR Text Key: 295813980
• Report Number: 2029046-2022-01090
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30698280L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2022
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE; UNK_CARTO 3