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

Model Number D134805

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has not returned for analysis, however, a picture and video were provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 13-year-old male patient (69kg) underwent an ischemic ventricular tachycardia - left (l-isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The catheter became knotted and required surgical intervention to remove.Mapping was done with thermocool® smart touch® sf bi-directional navigation catheter in the left ventricle (retrograde aortic access), ablation was done correctly and successfully with thermocool® smart touch® sf bi-directional navigation catheter.The doctors decided that the procedure was done correctly so they started to retreat the catheters from the patient.When they tried to take out the thermocool® smart touch® sf bi-directional navigation catheter from the left ventricle, they pulled the catheter out but some how they pulled it out of the ventricle with a curve.Therefore, the catheter was inside the aorta with a curve.The doctors wanted to get rid of the curve, so they started pulling, pushing, adding more curve and rotating but they did not succeed.By doing this, the catheter started to tangle up inside the artery until it made a knot.The catheter was stuck by the right thigh of the patient.The patient was transferred to the operating room to retrieve the catheter from the right thigh of the patient.The surgery was delayed due to the reported event for 150 minutes.The procedure was successfully completed.Additional information was received.In the physician¿s opinion, the delay did not contribute to a death or a serious injury to the patient.The physician¿s opinion on the cause of this adverse event is the physician¿s handling of the catheter.The physician does not blame the catheter.The patient outcome of the adverse event was fully recovered (no residual effects).The patient did not require extended hospitalization because of the adverse event.There was difficulty experienced while maneuvering the catheter or during the withdrawal.No sheath was used in procedure.There was no detachment of any component.The loop/tip did not become unknotted.The issue did not result in exposure of any internal catheter components or sharp edges.The event was assessed mdr reportable for both malfunction issues of ¿medical device entrapment with excessive manipulation required¿ and ¿knotted catheter¿.In addition, the adverse event was assessed as mdr reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

It was reported that a patient underwent an ischemic ventricular tachycardia - left (l-isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The catheter became knotted and required surgical intervention to remove.An x-ray video was received for evaluation following biosense webster's procedures.The video investigation was completed on (b)(6)2022.According to the x-ray video provided by the customer, the thermocool smarttouch sf catheter was observed knotted inside the patient's body.This condition is related to the customer complaint.At this time, it is not possible to determine the root cause of the knotted condition.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the video received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15637173
• MDR Text Key: 302057683
• Report Number: 2029046-2022-02583
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30707108L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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: SMARTABLATE GENERATOR KIT-WW
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 69 KG