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 Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Aortic Dissection (2491)

Event Date 10/05/2016

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: stockert generator (model# and serial# unknown).Carto 3 rmt system (model# and serial# unknown).(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a navistar® rmt thermocool® electrophysiology catheter and suffered a vascular dissection.Post-procedure, after draping, the patient became hypotensive and a retrograde tear (aortic dissection) was noticed.There is no information regarding intervention.Patient was reported to be in stable condition.There is no information regarding extended hospitalization or patient outcome.Physician¿s opinion regarding the cause of the adverse event was that it was related to sheath removal.It was also reported that while attempting to perform respiratory gating with the navistar catheter, it immediately failed.Respiratory data was not available.Visitag displayed as gray, there was no grid, and points disappeared.At the time of failure, the navistar was in a good position and there were no errors on the system.Second attempt also failed.Impedance filter was set to a 0-1 decrease in ohms.It was advised to re-load the carto application, but the staff was unable to re-load.Catheter was changed, issue was resolved, and lost visitag information was retrieved.There was no unwanted ablation.There were no issues related to cutoff values being exceeded.Physician continued the procedure without further troubleshooting.Stockert generator parameters: power was up to 40 watts with cut-off at 50 watts.Temperature did not exceed 38°c.Temperature cut-off was 42°c.Impedance cut-off was not exceeded.Two 8.5 french st.Jude medical sheaths were used.Since this adverse event might result in permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6070506
• MDR Text Key: 58926136
• Report Number: 9673241-2016-00755
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(11)160420(17)190331(10)17460245M
• 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
• Type of Report: Initial
• Report Date: 10/04/2016

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: 03/31/2019
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17460245M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2016
• 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
• Patient Age: 68 YR