MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW OUS 2.00MM X 15MM; CATHETER, BALLOON TYPE

Catalog Number M0032072415200

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

Patient Problems Stroke/CVA (1770); Hemorrhage, Cerebral (1889)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

The device was disposed in the hospital.

Event Description

It was reported that angioplasty using the first balloon and then the second balloon (subject device) was performed to treat 75% v4 vertebral artery (va) close to posterior inferior cerebellar artery (pica) stenosis.Both devices were inflated to nominal pressure one time each during 30 seconds.The hemorrhage due to the posterior superior alveolar artery (psa) rupture occurred after angioplasty and resulted in a stroke.The procedure and "dural anti drugs" were stopped.The event was resolved with no residual effect.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The device was not available for analysis.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.Hemorrhage and stroke 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 that angioplasty using the first balloon and then the second balloon (subject device) was performed to treat 75% v4 vertebral artery (va) close to posterior inferior cerebellar artery (pica) stenosis.Both devices were inflated to nominal pressure one time each during 30 seconds.The hemorrhage due to the posterior superior alveolar artery (psa) rupture occurred after angioplasty and resulted in a stroke.The procedure and "dural anti drugs" were stopped.The event was resolved with no residual effect.

• Brand Name: FG GATEWAY OTW OUS 2.00MM X 15MM
• 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: 5072306
• MDR Text Key: 25611803
• Report Number: 3008853977-2015-00373
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2016
• Device Catalogue Number: M0032072415200
• Device Lot Number: 16570972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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): Required Intervention
• Patient Age: 45 YR