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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184); Contamination /Decontamination Problem (2895)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.The finding was identified on (b)(6) 2022.It was initially reported by the customer that during the lipv (left inferior pulmonary vein) ablation, only stsf positional information deviated downward at the moment of ablation.Noise contamination was also observed in the lab immediately after ablation.No error code.The doctor commented that there was blood in the stsf spring department.After 1 hour since the catheter was used, after both side pvi was completed, at the time of ablation for re-isolation for lipv spontaneous relapse.The issue was not resolved after replacing the cable.Resolved by changing the catheter.The procedure was completed without patient's consequence.Noise is not mdr-reportable.Blood on device is not mdr-reportable.Hole in the pebax is mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).Device evaluation details: visual analysis of the returned sample revealed foreign material inside the pebax on the smart touch bidirectional sf device.The sensor functionality test was performed, per bwi procedures.No sensor issues were observed.During the sensor functionality test, the device was displayed correctly.An electrical test was performed in accordance with bwi procedures.The catheter passed the electrical values within specification.However, the foreign material inside the pebax could cause visualization or ecg errors.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.It should be noted that device failure is multifactorial.The instructions for use contain the following precautions: flush the catheter with heparinized saline prior to insertion into the body.A manufacturing record evaluation was performed for the finished device number 30706904l, and no internal actions related to the complaint were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: 14988533
• MDR Text Key: 304178764
• Report Number: 2029046-2022-01586
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2022

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: 01/06/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30706904L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• 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: ABBOTT AGILIS SMALL CARVE