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

Model Number D-1260-04-S

Device Problem No Display/Image (1183)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.Concomitant products: carto 3 system, model # m-4800-01, s/n: (b)(4).Smartablate generator (1 of 2), model # m-4900-07, s/n: (b)(4).Smartablate generator (2 of 2), model # m-4900-07, s/n: (b)(4).Manufacturer's ref.No: (b)(4) are related to the same incident.

Event Description

It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with two (2) 8mm navigational bi-directional catheters and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, the smartablate generator would not display impedance for the two (2) 8mm navigational bi-directional catheters.The cables were replaced, the generator was re-booted, the generator was exchanged, and pace routing was confirmed to be disabled without success.The 8mm navigational bi-directional catheters were exchanged for a thermocool smarttouch uni-directional catheter.The smartablate generator initially did not display impedance for the smarttouch.The catheter connector was re-seated into the generator and the issue was resolved.During mapping with the smarttouch catheter, the patient became hypotensive and tamponade was confirmed via intracardiac echocardiogram.Pericardiocentesis yielded 150-200cc.The patient was reported to be in stable condition.Physician did not provide a causality opinion.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with an 8mm navigational bi-directional catheter and suffered a cardiac tamponade requiring pericardiocentesis.The returned device was visually inspected and was found in good condition.Per the event, the catheter was tested for electrical performance, temperature response and generator compatibility, and was found within specifications.A deflection test was performed, which the catheter passed.The catheter was then evaluated for eeprom, and the catheter sensor functionality was tested on the carto system.The catheter was recognized by carto 3 system with no errors and proper visualization.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.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.The catheter passed all specifications.The root causes of the tamponade and impedance issue remain unknown.The instructions for use state that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5938003
• MDR Text Key: 54270435
• Report Number: 9673241-2016-00562
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: (01)10846835003048(11)160229(17)190131(10)17419131M
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068/S6
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: D-1260-04-S
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 17419131M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• 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