MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY MR JP 2.00MM X 12MM; CATHETER, BALLOON TYPE

Catalog Number M0032072112200

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

Patient Problems Fistula (1862); Vascular Dissection (3160)

Event Date 11/15/2014

Event Type  Injury  

Event Description

It was reported that following balloon (subject device) angioplasty and stent placement in the left supraclinoid internal carotid artery (ica), the left ica angiogram showed a dissection and ccf (carotid-cavernous fistula) near the treated area.A second stent was deployed for treatment.The patient mrs (modified rankin scale) pre and post procedure were 0; however, the dissection and ccf were ¿¿unrecovered¿¿ no additional information has been received.

Event Description

It was reported that following balloon (subject device) angioplasty and stent placement in the left supraclinoid internal carotid artery (ica), the left ica angiogram showed a dissection and ccf (carotid-cavernous fistula) near the treated area.A second stent was deployed for treatment.The patient mrs (modified rankin scale) pre and post procedure were 0; however, the dissection and ccf were ¿¿unrecovered¿¿ additional information received indicated the ccf was related to the dissection, and that the cause for the dissection was unclear.The current patient condition is unknown.

Manufacturer Narrative

The subject device will not be returned because it was disposed.

Manufacturer Narrative

The subject device was not returned; therefore, an analysis could not be performed.The device history record review confirms that the device met all material, assembly and performance specifications.Because the reported event is a known physiological effect of the procedure noted with the directions for use and/or device labeling, a cause of anticipated procedural complication was assigned.

• Brand Name: FG GATEWAY MR JP 2.00MM 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; maple grove MN 55311
• Manufacturer Contact: kathleen shin ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 4492436
• MDR Text Key: 5566051
• Report Number: 3008853977-2015-00045
• 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: Initial,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2016
• Device Catalogue Number: M0032072112200
• Device Lot Number: 15857882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 02/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2013
• 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
• Treatment: WINGSPAN STENT SYSTEM (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR