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); Electrical Shorting (2926)

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

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.(bwi) product analysis lab received the device on 2/01/2021.The device evaluation was completed on 3/31/2021.Visual analysis of the returned sample revealed reddish material in the pebax sleeve.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 105 and 106 were observed.A failure analysis was performed, and the catheter was dissected on the tip area and a loss of electrical continuity at the sensor was found.It was determined that the root cause was an internal failure of the sensor.Additionally, a scanning electron microscope (sem) testing was performed on the pebax surface, and a hole was found.Magnetic failure could be related to the blood inside the pebax, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30441724m number, and no internal action was found during the review.The instructions for use (ifu) contain the following precautions: immediately disconnect body surface ecg cable and all catheter extension cables from the piu and press acknowledge in the caution window, to enable ablation through the piu.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 (stsf) and the biosense webster inc, (bwi) product analysis lab found reddish material in the pebax sleeve and a hole was found.No internal parts exposed.Initially, it was reported that for the 2nd (afib) case, gap mapping of the pulmonary vein (pv) was performed with a pentaray.After mapping, energized the left pulmonary vein (lpv) posterior with the stsf catheter to energize the gap location.The catheter moved regularly when the power was turned on.The movement of the catheter intermittently increased when the power was turned on.After a while, it settled down, and the energy delivery was continued.Then, error 7 occurred and the power cannot be supplied.Pull out the front category of piu and restarted.Since no error occurred, the procedure resumed, but an error occurred again when the power was turned on.After replacing the stsf and energizing, the error no longer occurred, so the procedure continued.There was no signal noise / signal loss issue.There was no patient consequence.The current leakage-device disruption issue is not mdr reportable.This issue is highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety is unaffected by this issue.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and on 3/31/2021, a reddish material in the pebax sleeve was observed on the thermocool stsf.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 3/31/2021.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 11751140
• MDR Text Key: 266683370
• Report Number: 2029046-2021-00693
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30441724M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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