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

Model Number D134702

Device Problems Material Puncture/Hole (1504); Temperature Problem (3022)

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

Event Date 05/20/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2022.The device evaluation was completed on (b)(6) 2022.The device was returned to biosense webster for evaluation.A visual inspection and temperature and impedance test of the returned device were performed following with bwi procedures.Visual analysis of the returned sample revealed foreign material inside the pebax on the thermocool® smart touch® sf uni-directional navigation catheter.The device was inspected on the pebax area, under microscopy, to identify if there was damage on the pebax, that caused the foreign material inside the pebax.A hole was found in the pebax.The foreign material could be related to the temperature issue but it could not be conclusively determined.A temperature and impedance test was performed and no temperature was displayed due to an open circuit on the tip area.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: (b)(4).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia - asc procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a hole on the pebax.Initially, it was reported that there was no temperature displayed on the smartablate generator a couple of minutes after the catheter was plugged into the patient interface unit (piu) and before ablation had begun.The cable was replaced with no resolution.When the catheter was replaced, the issue resolved.The smartablate generator was operating per specifications and is not responsible for the product issue.The no temperature displayed issue was assessed as not mdr reportable.The ablation cannot be performed since there is no radio frequency energy applied.The most likely consequence was an intraprocedural delay.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 (b)(6) 2022, foreign material was found in the pebax area.The device was inspected on the pebax area, under microscopy, and a hole was observed.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding is (b)(6) 2022.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 14941300
• MDR Text Key: 304443478
• Report Number: 2029046-2022-01529
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: 07/06/2022

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: 03/17/2023
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30739914L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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; UNK_SMARTABLATE GENERATOR