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); Device Sensing Problem (2917)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 23-jul-2021.The device evaluation was completed on 09-aug-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, impedance and temperature evaluation of the returned device.Visual analysis of the returned sample revealed a hole and reddish material inside of the pebax in the smart touch sf catheter.Generator testing was performed, in accordance with bwi procedures.The catheter was working correctly, and no impedance or temperature issues were detected during the analysis.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Even though no temperature issue was observed, it should be noted that for product force failure, the instructions for use contain the following information in the carto 3 system manual that should be considered: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.The customer complaint regarding temperature issue was unable to be duplicated during the product investigation.However, the damaged pebax could be related to force issues.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure, but this cannot be conclusively determined.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product investigation lab observed a hole on the pebax.Initially it was reported by the biosense webster, inc.Representative that after not being there at the facility for two weeks, the catheter was set aside with a note that said, ¿temperature error¿.The normal troubleshooting steps were taken.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure was continued.No information for procedure type or a specific date of the procedure was provided.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The temperature sensor error issue was assessed as not mdr reportable.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 investigation lab received the device for evaluation and per the evaluation completion on 09-aug-2021 there was reddish material found inside the pebax, and a hole was observed.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 09-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: 12419427
• MDR Text Key: 278447667
• Report Number: 2029046-2021-01421
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30523803M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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