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

Model Number D134805

Device Problems Contamination (1120); Insufficient Cooling (1130); Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895); Excessive Heating (4030)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual inspection was performed, and reddish material and a hole were observed in the pebax.Then, the device was connected to the generator and temperature value was observed however, no impedance values were observed due to an internal open circuit.In addition, an irrigation test was performed, and the device was partially irrigating.Further investigation revealed that dried reddish material was occluding inside the irrigation dome.During the test, no temperature issues were observed on the handle.A manufacturing record evaluation was performed for the finished device 30875195l number, and no internal action was found during the review.The foreign material inside the pebax, high temperature and the biological material reported by the customer were confirmed.However, handle warms/heat up could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.It should be noted that product failure is multifactorial.As part of biosense webster'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 a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the bwi product analysis lab later identified a hole in the pebax with reddish material inside.During the procedure--after starting ablation--, the temperature on the generator rose until cutoff temperature for several times.Ablation was stopped automatically.Visible inspection of the catheter showed blood in chamber of force sensor.The handle was very hot.No charring visible.Catheter was changed and procedure was finished successfully.No patient consequences were reported.Additional information: there was no difficulty when maneuvering or withdrawing the catheter.No physically damage on catheter tip or other parts of catheter were noted mid- or post-procedure.Hole in the pebax is mdr-reportable.

• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17004249
• MDR Text Key: 316715683
• Report Number: 2029046-2023-01157
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• 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: 30875195L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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: UNSPECIFIED GENERATOR; VIZIGO SHEATH - 8.5 MEDIUM