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

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) 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).(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.

• 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: 5938015
• MDR Text Key: 54274716
• Report Number: 9673241-2016-00563
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: (01)10846835003048(11)151215(17)181130(10)17380030M
• 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
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: D-1260-04-S
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 17380030M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2015
• 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