MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW JP 1.50MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072009150

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

Patient Problem Vascular Dissection (3160)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that the patient underwent angioplasty with the subject balloon catheter.A non-severe vessel dissection occurred at the right internal carotid artery (ica).A stent was placed to treat the dissection.The procedure was completed without problems.There were no clinical consequences to the patient.

Manufacturer Narrative

The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Based on the investigation results and available information an assignable cause of anticipated procedural complication was assigned to the as reported patient vessel dissection, since the issue is due to a known physiological effect of the procedure and or/ patient condition noted with the direction for use, device labelling and/or risk documentation files.

Event Description

It was reported that the patient underwent angioplasty with the subject balloon catheter.A non-severe vessel dissection occurred at the right internal carotid artery (ica).A stent was placed to treat the dissection.The procedure was completed without problems.There were no clinical consequences to the patient.

• Brand Name: FG GATEWAY OTW JP 1.50MM X 9MM
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 8528703
• MDR Text Key: 142396705
• Report Number: 3008853977-2019-00035
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Catalogue Number: M0032072009150
• Device Lot Number: 22807391
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention