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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 11/23/2021

Event Type  malfunction  

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, (bwi) product analysis lab observed a reddish material in the pebax, and a hole was found on the catheter.Initially, it was reported that about half-way through the procedure, there was noise displayed on the distal and proximal ablation signals on the carto 3 and recording system.The caller reported that the force reading was displaying "hi" on the carto 3 system when coming on for ablation as well.The cable was replaced with no resolution.The catheter was replaced, and the issue resolved, and the procedure continued.The carto 3 system was operating per specs and was not responsible for the product issue.No adverse patient consequences were reported.The bad/partial ecg issue was assessed as not mdr reportable.The risk to the patient is low.The force high issue was assessed as not mdr reportable.The issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation.Visual analysis of the returned sample revealed that reddish material was observed in the pebax, and a hole was found on the thermocool® smart touch® sf bi-directional navigation catheter.This finding was assessed as mdr reportable.The awareness date for this reportable lab finding is 21-jan-2022.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 07-jan-2022.The device evaluation was completed on 21-jan-2022.The product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection, screening test and electrical evaluation of the returned device.Visual analysis of the returned sample revealed that a reddish material was observed in the pebax, and a hole was found on the thermocool® smart touch® sf bi-directional navigation catheter.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested, and it was working properly, the force values were observed within specifications.The catheter was tested on the generator and the temperature and impedance values were observed within specifications.The evaluation determined that the cause of pebax damage failure cannot be established.The event described force high was unable to be duplicated during the product investigation.However, the blood found inside the pebax area may have contributed to the high force issue reported.During the product analysis, the lot number for the device was able to be retrieved.A manufacturing record evaluation was performed for the finished device 30644181l number, and no internal action was found during the review.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated: in the carto 3 system manual: the force sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.(b)(4).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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13539654
• MDR Text Key: 289007904
• Report Number: 2029046-2022-00311
• 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: 02/15/2022

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: 09/29/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30644181L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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: UNK BRAND CABLE; UNK BRAND CATHETER; UNK_CARTO 3