MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1201-19-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 02/03/2015

Event Type  Death  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record (dhr) for the lot number 15841499m has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4) concomitant products: pentaray navigational eco catheter: model #: d-1282-11-s, lot #: 17148558l, carto 3 system, model #: fg-5400-00k, serial #: (b)(4).(b)(4) are related to the same incident.(b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia procedure with a smart touch bidirectional catheter and a navistar ds catheter.The procedure was completed successfully.At some point following the procedure, the patient expired.It was not known if there was any medical intervention administered prior to the patient expiring.The length of time between the procedure and the patient's death was unknown.An autopsy was performed at another facility which suggested that the patient received too much ablation.The full autopsy report was not available.The physician related the cause of death as unknown.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 5287122
• MDR Text Key: 33232906
• Report Number: 9673241-2015-00902
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010068
• 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: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2016
• Device Model Number: D-1201-19-S
• Device Catalogue Number: NS7TCF8L174HS
• Device Lot Number: 15841499M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2013
• 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): Death