MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1266-01-S

Device Problem Human-Device Interface Problem (2949)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/03/2015

Event Type  Injury  

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) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).Methods: no testing methods performed; results: no results available since no evaluation performed; conclusion: device discarded by user, unable to follow-up.Concomitant medical products: carto 3 system, model #:m-4800-01, serial #: (b)(4).Stockert 70 system, model #: m-5463-01, serial #: (b)(4).Cool flow pump, model #: m-5491-02, serial #: (b)(4).(b)(4).

Event Description

It was reported that a patient, underwent an idiopathic ventricular tachycardia (idvt) procedure with a navistar rmt thermocool catheter and suffered a cardiac tamponade which required a pericardiocentesis.During the procedure post ablation, a pericardial effusion was noticed as the patient's blood pressure dropped.It was discovered post epicardial /endocardial mapping and ablation.The pericardial effusion was confirmed by intracardiac echocardiography (ice).There were 400cc of blood removed via tap used for epicardial access.The patient was reported to be in stable condition while performing the pericardial tap.The patient's condition post procedure was not known.A transseptal puncture had been performed.However, the products used for the transseptal puncture were not known.The generator was set to power control mode.The parameters were not known.The overall time of ablation was not known since the site of injury was not known.The flow setting was set to 30 ml/min.There was no error messages observed on the biosense webster equipment during the procedure.The act range maintained during the procedure was not known.A factor that may have contributed to the event was patient disease.There is no information about the hospitalization.The physician's opinion regarding the cause of this adverse event is that it was procedure related.

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY 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: 5115343
• MDR Text Key: 27178723
• Report Number: 9673241-2015-00694
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17252341M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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): Life Threatening; Required Intervention