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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30438714m number, and no internal actions related to the complaint was 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).

Event Description

It was reported that a male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered vascular dissection (aortic dissection) requiring unspecified intervention and prolonged hospitalization.During the procedure, the physician felt resistance when passing the thermocool® smart touch® sf bi-directional navigation catheter through the aorta.A second physician was called, and it was found the aorta was dissected.The issue was discovered and confirmed by injecting contrast and using fluoro.The patient was reported to be in stable condition.Unspecified intervention was provided.Patient was sent for a computerized tomography (ct).Ct results were not provided.The patient required prolonged hospitalization and had fully recovered from the event.Physician potentially relates the causality of the event to excessive force being applied with the thermocool® smart touch® sf bi-directional navigation catheter.It was confirmed that a bwi 8 fr preface sheath was used for access; however, this event is being coded and reported under the thermocool® smart touch® sf bi-directional navigation catheter only as with the information available, it is most likely the issue occurred due to excessive force applied with the catheter.Should more information become available, this event may be reassessed.

• 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: 11023367
• MDR Text Key: 222316289
• Report Number: 2029046-2020-01944
• 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: Physician
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30438714M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention