MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1347-00

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

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 since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® sf uni-directional nav catheter and suffered a cardiac tamponade, which required pericardiocentesis.The physician reported a tamponade on the patient eight hours after a pulmonary vein isolation procedure.The catheter was used at 25 watts power at all sites of ablation.There is no information about hospitalization and the patient¿s current status is currently unknown.The physician did not provide a casualty opinion for the adverse event.However, it is noted, the physician believes that the tip of the catheter is very stiff and he does not yet have the habit to look at the displayed contact force, although he is trained to use this catheter.A transseptal puncture was performed with an unknown brand needle.The ablation cycle time at the site of injury is unknown because the injury site is unknown as the tamponade was discovered hours after the procedure.There are no known patient factors that might have contributed to the event.There were no reported error messages on biosense webster inc.Systems during the procedure.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6119498
• MDR Text Key: 60625571
• Report Number: 2029046-2016-00247
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1347-00
• Device Catalogue Number: D134700
• Device Lot Number: UNKNOWN_D-1347-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Required Intervention