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

Model Number D134805

Device Problems Image Orientation Incorrect (1305); High Readings (2459)

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

Event Date 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

The catheter was returned to biosense webster for evaluation on (b)(6) 2022.The device evaluation was completed on (b)(6) 2022.Bwi conducted a visual inspection and shaft proximity interference (spi) screening test of the returned catheter.Visual analysis of the returned catheter revealed reddish-brown material inside and a hole in the pebax of the thermocool® smart touch® sf bi-directional navigation catheter.The spi screening test was performed, in accordance with bwi procedures.The returned sample was connected to carto 3 system, and the force values were observed within specifications.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The evaluation determined that the cause of pebax damage failure cannot be established.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.The events described force issue were unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issue.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a hole in the pebax.Initially it was reported that whenever coming on ablation, the carto 3 system displayed a "hi" force alert and the force vector inverted.The thermocool® smart touch® sf bi-directional navigation catheter was re-zeroed multiple times, without resolution.The cable was replaced without resolution.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue resolved.The procedure continued.The carto 3 system was operating per specifications and it was stated that it was not responsible for the product issue.There was no patient consequence reported.The force high 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 force vector inverted issue was assessed as not mdr reportable.Despite the incorrect force vector visualization, the device can function as intended, because the catheter can still be displayed using fluoroscopy and carto 3 navigation system.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The risk to the patient is low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2022 there was reddish-brown material inside and a hole in the pebax of the thermocool® smart touch® sf bi-directional navigation catheter.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 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: 15375079
• MDR Text Key: 305540360
• Report Number: 2029046-2022-02140
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• 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: 30799647L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• 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 CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNK_CARTO 3