MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY MR JP 3.50MM X 20MM; CATHETER, BALLOON TYPE

Catalog Number M0032072120350

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

Patient Problem Vasoconstriction (2126)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported that the during balloon angioplasty to treat the stenosed right vertebral artery, vessel spasm occurred.The physician deployed a stent to secure vessel patency.24 hours post procedure the patient developed a cerebral infarction; however, no treatment was administered because it was assessed as non-serious.The physician's opinion to the cerebral infarction is that it was not related to the deployed stent because it occurred in a non-treated area.The patient recovered without any adverse consequences.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, vessel spasm is a known risk associated with endovascular procedures and is noted as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that the during balloon angioplasty to treat the stenosed right vertebral artery, vessel spasm occurred.The physician deployed a stent to secure vessel patency.24 hours post procedure the patient developed a cerebral infarction; however, no treatment was administered because it was assessed as non-serious.The physician¿s opinion to the cerebral infarction is that it was not related to the deployed stent because it occurred in a non-treated area.The patient recovered without any adverse consequences.

• Brand Name: FG GATEWAY MR JP 3.50MM X 20MM
• 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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6001286
• MDR Text Key: 56535297
• Report Number: 0002134265-2016-00024
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: M0032072120350
• Device Lot Number: 17587211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2015
• Is the Device Single Use?: No
• 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: 69 YR