MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Model Number D-1327-00-S

Device Problem Difficult To Position (1467)

Patient Problems Pain (1994); Aortic Dissection (2491)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure for idiopathic ventricular tachycardia with a thermocool smarttouch bi-directional navigation catheter and suffered a vascular dissection requiring surgical intervention (stent).Post-procedure, the patient returned to the hospital reporting groin pain.Computed tomography (ct) revealed an aortic dissection involving the iliac artery.Stent was surgically placed.Patient was reported to be in stable condition.Patient required one extra day of hospitalization for recovery from surgery.Patient fully recovered.Physician¿s opinion regarding the cause of the adverse event is that it was related to the difficulty encountered while traversing the aortic valve with the ablation catheter.Physician indicated that there was no product malfunction.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 6215633
• MDR Text Key: 63639945
• Report Number: 9673241-2016-00931
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1327-00-S
• Device Catalogue Number: D132700
• Device Lot Number: UNKNOWN_D-1327-00-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• 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; Required Intervention