MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC INQUIRY AFOCUSII? (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F; CATHETER, ELECTRODE RECORDING

Model Number IBI-87008

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Brain Injury (2219)

Event Date 10/15/2014

Event Type  Injury  

Event Description

Related manufacturer reference: 3005188751-2014-00136, 3005188751-2014-00137, 3005188751-2014-00138.Following the completion of a pulmonary vein isolation procedure, the patient experienced a cva.Average blood pressure was 140 mm/hg with peaks of 230 mm/hg and acts were maintained at 250 seconds throughout the procedure.At the end of the procedure, the patient was awake and responsive, but aphasic.A neurologic consultation was completed and a cranial ct and mr scans were done.The ct scan was negative for bleeding, but the mr scan revealed a small lesion in the brain.A second ct scan after 24 hours revealed a second cerebral lesion in the frontal area of the brain.The patient is currently awake and responsive, but remains aphasic.There were no performance issues with any sjm device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported cva could not be conclusively determined.

• Brand Name: INQUIRY AFOCUSII? (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4237133
• MDR Text Key: 5076369
• Report Number: 2030404-2014-00099
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2014

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: IBI-87008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: TACTICATH QUARTZ ABLATION CATHETER; BRK TRANSSEPTAL NEEDLE; SWARTZ BRAIDED TRANSSEPTAL INTRODUCERS X 2
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 100