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

Model Number D-1197-17-S

Device Problem High impedance (1291)

Patient Problems Stroke/CVA (1770); Dysphasia (2195); Loss of consciousness (2418); Patient Problem/Medical Problem (2688); Pericardial Effusion (3271)

Event Date 12/15/2015

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.(b)(4).

Event Description

It was reported that a male patient underwent a pulmonary vein isolation procedure under general anesthesia for atrial fibrillation with a navistarthermocoolelectrophysiology catheter and suffered a cerebrovascular accident and pericardial effusion requiring no intervention.The procedure was completed successfully.Following the procedure, while the anesthetist was waking the patient, it was discovered that the patient had decreased responsiveness and significantly reduced right sided mobility.Cerebrovascular accident was confirmed via computed tomography.In addition, a small, asymptomatic pericardial effusion was discovered via echocardiography.Patient's hemodynamic profile remained stable throughout the procedure.At the onset of ablation, non-mdr reportable high impedance values (approximately 500 ohms) caused the stockert generator to interrupt ablation.The indifferent electrode was replaced and repositioned and the catheter cable was replaced, providing resolution.There were several episodes during ablation where impedance increased up to 250 ohms and ablation was interrupted.The catheter was visually inspected, found to be within normal limits, and procedure continued.The patient did require hospitalization related to the cerebrovascular accident; however no medical or surgical intervention was required.Additional information was received indicating that the patient was in critical condition immediately following the procedure and was having difficulties speaking.Patient reported to be improving.It is unknown at what point in the procedure that the cerebrovascular accident occurred as it was discovered post-procedure.The physician did not provide causality opinion regarding this adverse event.

Manufacturer Narrative

Additional information was omitted in error on initial report.Below is additional information on this event.A transseptal puncture was performed using a st.Jude medical needle.Sheath used was a st.Jude medical agilis.Generator settings: power control mode at 25-30 watts with temperature cut-off at 45 degrees celsius.Irrigated catheter at 15-30 ml/min.Patient did receive anticoagulation during the procedure with acts maintained in an unknown range.

• Brand Name: NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5360654
• MDR Text Key: 35686986
• Report Number: 2029046-2016-00001
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: UNKNOWN_D-1197-17-S_IRW
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2012
• 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; Disability