MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW JP 3.00MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072009300

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

Patient Problem Thrombosis (2100)

Event Date 06/22/2015

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported in a post market surveillance case that an acute occlusion occurred after angioplasty was done with a balloon (subject device) for a major stroke of the internal carotid artery.Therefore angioplasty with another balloon, deployment of a stent, and intra-arterial injection of argatroban and ozagrel were performed.Angioplasty with another balloon was done 2 more times and the patient recovered.No other information is available.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.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.Thrombosis is a known and anticipated complication to these types of procedures and is 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 an acute occlusion occurred after angioplasty was done with a balloon (subject device) for a major stroke of the internal carotid artery.Therfore angioplasty with another balloon, deployment of a stent, and intra-arterial injection of argatroban and ozagrel were performed.Angioplasty with another balloon was done 2 more times and the patient recovered.No other information is available.

Manufacturer Narrative

This is the first of 2 reports.

Event Description

It was reported in a post market surveillance case that an acute occlusion (1st adverse event) occurred after percutaneous transluminal angioplasty (pta) was done with a balloon (subject device) for a major stroke of the internal carotid artery.A pta with another balloon and deployment of a stent were performed.Later on (undefined date), thrombosis (2nd adverse event) within the stent occurred.Pta was performed twice and intra-arterial injection of anticoagulant and platelet aggregation inhibitor was done.The patient eventually recovered.This report concerns the first adverse event.

• Brand Name: FG GATEWAY OTW JP 3.00MM 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: 5097744
• MDR Text Key: 26545680
• Report Number: 3008853977-2015-00386
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Followup,Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2015
• Device Catalogue Number: M0032072009300
• Device Lot Number: 15653205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2012
• 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: 58 YR