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

Model Number D-1327-04-S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Perforation (2001)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4) concomitant product: carto 3 system, model #: m-4800-01, serial #: (b)(4).(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for ischemic ventricular tachycardia with a thermocool smarttouch bi-directional navigation catheter and suffered a vessel perforation requiring surgical intervention.During the procedure, the catheter became entrapped in the artery.The physician discovered entrapment when he was attempting to enter the left ventricle via a retrograde approach.The physician indicated that he thought the puller wire was broken.The catheter handle was cut to free the catheter.The vascular surgeon was consulted.The patient was diagnosed with a right femoral artery rupture and received 3 stents.The patient required extended hospitalization for 2 extra nights as a result of this adverse event.The patient was reported to be in stable condition.The physician's opinion regarding the cause of the adverse event was that it was related to the puller wire getting broken, therefore it was a product related malfunction.Since this adverse event required medical or surgical intervention to preclude 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 ; 9497893837
• MDR Report Key: 5504366
• MDR Text Key: 40482782
• Report Number: 9673241-2016-00194
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• 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: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: D-1327-04-S
• Device Catalogue Number: D132704
• Device Lot Number: 17368377M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2015
• 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
• Patient Age: 70 YR
• Patient Weight: 73