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 Insufficient Information (3190)

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

Event Date 07/16/2015

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 for the lot number 17220685m was reviewed and no anomalies were found related to this complaint.In addition, dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).Concomitant products: lasso nav 2515 eco catheter.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a navistar rmt thermocool catheter and after the procedure suffered a cardiac tamponade which required drainage.The patient's medical history is unknown.During the procedure isolation was performed on the pulmonary veins.A transseptal puncture was performed.The generator was set to power mode control.An 8f sheath was used.However, the sheath brand was unknown.After the procedure, it was found that the patient had a pericardial effusion which needed drainage.The patient did require one extra day of hospitalization.The patient was reported to be in stable condition at the time the complaint was reported.The physician did not provide a causality opinion for the cause of this adverse event.

Manufacturer Narrative

(b)(4) the correct codes should reflect as the following: methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.(b)(4).

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4998340
• MDR Text Key: 22819672
• Report Number: 9673241-2015-00513
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/17/2015

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: 04/30/2018
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17220685M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2015
• 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): Hospitalization; Life Threatening; Required Intervention