MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR? ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D-1183-07-S

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Death (1802); Ischemia (1942); Pneumonia (2011)

Event Date 02/01/2015

Event Type  Death  

Event Description

This complaint is from literature source with title: ¿pathology in the late phase after extensive and ostial pulmonary vein ablation for atrial fibrillation, 2015 heart rhythm society¿.It was stated that the navistar catheter was used for the pulmonary vein isolation on left atrium after transseptal puncture.The procedure was completed without any patient consequence.Right after the procedure, the patient developed symptom of stroke.Ischemic nest was observed at the distal portion of the left cerebral blood vessel and the physician diagnosed it stroke.After 7 months, the patient passed away due to pneumonia.The patient was at the age of 62 and a male.

Manufacturer Narrative

(b)(6).(b)(4).

• Brand Name: NAVISTAR? ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: jaime chavez ; 9098398483
• MDR Report Key: 4532700
• MDR Text Key: 16465537
• Report Number: 2029046-2015-00044
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2015

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 Model Number: D-1183-07-S
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: UNKNOWN_D-1183-07-S
• Other Device ID Number: (01)10846835000597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR