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

Model Number D134805

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895); Device Sensing Problem (2917)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2021.The device evaluation was completed on (b)(6) 2021.The catheter was returned to biosense webster for evaluation.Bwi conducted a visual inspection, generator and shaft proximity interference (spi) screening test of the returned catheter.Visual analysis of the returned catheter revealed reddish material inside and a hole on the pebax on the stsf catheter.The shaft proximity interference screening test was performed, in accordance with biosense webster, inc.Procedures.The returned sample was connected to carto 3 system and the force values were observed within specifications.A generator test was performed on the catheter and it was found within specifications.No temperature malfunction was observed.The evaluation determined that the cause of the pebax damage failure cannot be established.The event described force issue was unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issue.A manufacturing record evaluation was performed and no internal action was found during the review.As part of biosense webster, inc.'s quality process all devices are manufactured, inspected, and released to approved specifications.Although no force issue could be reached on the cause of the reported event, to minimize force issues, the following guidelines should be followed.In order to achieve optimal force reading accuracy and stability, allow the catheter to warm up for 2 minutes after connection to the carto¿3 system, prior to use of the force feedback feature.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 a hole on the pebax.Initially it was reported that the carto 3 system displayed a sensor error (unknown error code by the caller) for the thermocool® smart touch® sf bi-directional navigation catheter.The cable was replaced without resolution.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue was resolved.The caller stated that when the thermocool® smart touch® sf bi-directional navigation catheter was pulled out of the body, there was "blood inside the clear tip of the catheter where the springs are." the carto 3 system was operating per specifications and was not responsible for this product issue.The sensor error issue was assessed as not mdr reportable.The catheter can not be used and must be replaced.The blood inside the clear tip of the catheter was assessed as not mdr reportable as there was no damage to the pebax integrity reported.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-aug-2021 there was reddish material and a hole on the pebax.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 06-aug-2021.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12405483
• MDR Text Key: 269309920
• Report Number: 2029046-2021-01424
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30547301M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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: CARTO 3 SYSTEM; NON BWI-PRUKA RECORDING SYSTEM; UNKNOWN BRAND BS ECG CABLE; UNKNOWN BRAND BS ECG CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE