MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY MR JP 3.50MM X 12MM; CATHETER, BALLOON TYPE

Catalog Number M0032072112350

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

Patient Problem Vascular Dissection (3160)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

The device was disposed in the hospital.

Event Description

It was reported that a balloon angioplasty (subject device) was performed to treat an asymptomatic cerebral infarction of the right 64% stenosed internal carotid artery.The balloon was inflated one time under nominal pressure of 6 atm for 5sec.However; after angioplasty a vessel dissection occurred.A stent was placed across the dissected area to treat the complication.The event was resolved with no residual effect.Two days post procedure, the patient was discharged.There was no clinical consequence to the patient.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot 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.However, vessel dissection is a known risk associated with endovascular procedures and is listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that a balloon angioplasty (subject device) was performed to treat an asymptomatic cerebral infarction of the right 64% stenosed internal carotid artery.The balloon was inflated one time under nominal pressure of 6 atm for 5sec.However; after angioplasty a vessel dissection occurred.A stent was placed across the dissected area to treat the complication.The event was resolved with no residual effect.Two days post procedure, the patient was discharged.There was no clinical consequence to the patient.

• Brand Name: FG GATEWAY MR JP 3.50MM X 12MM
• 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; model farm road; maple grove MN 55311
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6107680
• MDR Text Key: 60073244
• Report Number: 0002134265-2016-00032
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: M0032072112350
• Device Lot Number: 17518014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• 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): Other; Required Intervention
• Patient Age: 79 YR