MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-05-S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Chest Pain (1776); Pain (1994); Renal Failure (2041); Aortic Dissection (2491)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number can not be provided.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a (b)(6) year old (b)(6) patient underwent an ablation procedure for left ventricular premature ventricular contractions (pvcs) with a thermocool smarttouch bi-directional navigation catheter and suffered a vascular dissection (type b aortic dissection) requiring imaging and acute kidney failure requiring no medical or surgical intervention.After ablating some of the pvc sites, the catheter slipped back through the aortic valve.This required maneuvering the catheter back through the aortic arch, across the aortic valve, and re-positioning in the left ventricle.Approximately 30 minutes into the procedure, the patient reported pain radiating from her back to her chest.Physician carefully withdrew the catheter back into the aortic arch.Transthoracic echocardiogram revealed no cardiac abnormalities.While the catheter was in the aortic arch, the patient reported increased pain.Patient was normotensive.Catheter was withdrawn.Aortic arch angiogram revealed some flow abnormalities, but was difficult to assess.Remainder of procedure was aborted.Computed tomography (ct) revealed a type b aortic dissection.Patient was transferred to the intensive care unit for observation.Patient required extended hospitalization as a result of this adverse event for observation and follow-up ct scans to determine the need for intervention.It was noted that the patient had some renal dysfunction.Patient outcome was reported to be unchanged at the time of complaint report.There was no product malfunction reported.Physician did not provide a causality opinion.Since this adverse event might result in permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6207866
• MDR Text Key: 63382513
• Report Number: 9673241-2016-00895
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: UNK_D-1327-05-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR
• Patient Weight: 75