MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY MR JP 2.50MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072109250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Intracranial Hemorrhage (1891); Hydrocephalus (3272)

Event Date 04/13/2012

Event Type  Death  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported in a post market surveillance case that thrombectomy with the retriever was performed for a cardiogenic occlusion in the basilar artery.The artery did not recanalize.Angioplasty was done with the subject device and hydrocephalus due to intracranial hemorrhage occurred.Cerebral ventricle drainage was performed but the patient died.

Manufacturer Narrative

The device history record review could not be performed because the lot number of the device is not known.The device was not returned for analysis therefore visual inspection and functional testing could not be performed.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.Patient hemorrhage and death are known and anticipated complications to these types of procedures and are noted in the labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.

Event Description

It was reported in a post market surveillance case that thrombectomy with the retriever was performed for a cardiogenic occlusion in the basilar artery.The artery did not recanalize.Angioplasty was done with the subject device and hydrocephalus due to intracranial hemorrhage occurred.Cerebral ventricle drainage was performed but the patient died.

• Brand Name: FG GATEWAY MR JP 2.50MM X 9MM
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5336719
• MDR Text Key: 34734343
• Report Number: 3008853977-2015-00553
• Device Sequence Number: 0
• Product Code: PAV
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0032072109250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• 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
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 79 YR