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

Model Number D134805

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

On 7/13/2020, the bwi product analysis lab received the complaint device for evaluation.Initial visual analysis found no visual damage or anomalies.During a second inspection, the catheter was found with a dent on the dome; it could be related with the handling during the procedure; however, it cannot be conclusively determined.The catheter¿s outer diameter was measured, and it was found within specification.Then, the catheter was tested for deflection and failed.Further investigation revealed that the puller wire was found separate from ferrule inside the tip.The customer complaint regarding device entrapment or catheter tip became twisted was confirmed; however, the root cause of the puller wire slippage and dented dome 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 with the handling of the device during the procedure since the instructions for use (ifu) states that ¿do not use thermocool smarttouch catheters in patients with prosthetic valves.¿ a manufacturing record evaluation was performed for the finished device 30373766m number, and no internal actions related to the reported complaint condition were identified.All units are inspected prior leaving the facility and mre verified that this complaint unit was in good condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a device entrapment occurred requiring pharmaceutical intervention.It was reported that the thermocool® smart touch® sf bi-directional navigation catheter became entrapped in the left ventricle, around the chordae tendineae/papillary muscle.This occurred as the catheter was introduced retrogradely through the aortic valve and the catheter tip flipped from one papillary muscle to another.When attempting to free the thermocool® smart touch® sf bi-directional navigation catheter from the chordae tendineae the catheter tip became twisted around it.The patient was given adenosine to prolong the pr interval and relax the papillary muscle.This worked to free the catheter tip to make it unknotted and then it was successfully removed from the patient.The caller noted that the patient had a bioprosthetic mitral valve.The caller stated that there was no patient injury as a result of the catheter entrapment.No extended hospitalization was required.There was a fair amount of resistance while the catheter was in the left ventricle.The physician pushed 18 micrograms of adenosine, waiting for a p-r segment prolongation of 6 secs, then proceeded to cork the catheter free.They mentioned that while corking and pulling, there was no resistance.The sheath brand is unknown but it was 8 french.There was no detachment of any component.There was no exposure of any internal catheter components or sharp edges.The bwi sales representative provided a video of the issue but it could not be opened.The bwi sales representative then described that the video showed ice image of the catheter being stuck in the ventricle.You can see the tip the ablator (green tip enabled) wrap around the chordae.The tip is pushed against the anterior lateral papillary muscle, where the modular bands meet at the muscle.Since intervention (although not surgical) was required this event is considered a reportable malfunction.Based on the event description there is no indication that the tip was deformed but curved around the chordae.

• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10344388
• MDR Text Key: 201193811
• Report Number: 2029046-2020-00942
• 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: 07/09/2020

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: 03/19/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30373766M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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