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

Model Number D-1197-17-S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: st.Jude medical agilis transseptal needle.St.Jude medical agilis sheath.Full udi # information is unavailable since the lot number is unknown.(b)(4).

Event Description

It was reported that a female patient underwent an ablation procedure for idiopathic ventricular tachycardia with a navistar rmt thermocool catheter and suffered a cardiac tamponade requiring surgical intervention.During ablation, a steam pop occurred.After the ablation phase, the tamponade was confirmed, and the patient was taken for a thoracotomy and cardiac surgery.Additional surgery was required during the night after the event.The patient was hooked up to a cardiopulmonary bypass machine during the surgical intervention.Two days after the event, the patient was extubated and noted to be responsive.The physician¿s opinion is that the injury was procedure related, and not related to the catheter.It is unknown if anticoagulants were in use during the case, or if there were any patient factors that may have contributed to the injury.A transseptal puncture was performed with a st.Jude medical agilis transseptal needle.The sheath in use was a st.Jude medical agilis as well.The tamponade was discovered after ablation at several different sites, so the overall ablation time and exact site of injury are unknown.The generator was being used in temperature control mode at 43 degrees c and 45 w (titration unknown).The catheter irrigation was set at 30 ml/min.No errors presented on any biosense webster equipment during the procedure.

Manufacturer Narrative

On 01/18/2017, biosense webster received information that the catalog number of the catheter originally reported was incorrect.All relevant fields have been updated.(b)(4).

• Brand Name: NAVISTAR® 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 CA 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua CA 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6211168
• MDR Text Key: 63478527
• Report Number: 2029046-2016-00271
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup
• Report Date: 12/09/2016

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 Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: UNKNOWN_D-1197-17-S_JUA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention