MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW OUS 2.00MM X 15MM; CATHETER, BALLOON TYPE

Catalog Number M0032072415200

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

Patient Problems Stroke/CVA (1770); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that angioplasty was performed to treat a 70% basilar tip stenosis using two balloon catheters.The first balloon was unable to be inflated.Then the second balloon (subject device) was used and was unable to be inflated as well.After usage of the second balloon, the patient experienced a subarachnoid hemorrhage (sah) and the procedure was stopped.The patient did not wake up for a long time after the procedure and after the patient woke up, it was found that he had a stroke with one sided hemiplegia.No further details were provided.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.Patient hemorrhage, blood loss, patient stroke and one sided hemiplegia (paralysis) are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu); therefore, anticipated in nature.However, because the device was not returned the exact cause for the difficulties encountered with the device cannot be definitively determined.

Event Description

It was reported that angioplasty was performed to treat a 70% basilar tip stenosis using two balloon catheters.The first balloon was unable to be inflated.Then the second balloon (subject device) was used and was unable to be inflated as well.After usage of the second balloon, the patient experienced a subarachnoid hemorrhage (sah) and the procedure was stopped.The patient did not wake up for a long time after the procedure and after the patient woke up, it was found that he had a stroke with one sided hemiplegia.No further details were provided.

• Brand Name: FG GATEWAY OTW OUS 2.00MM X 15MM
• 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: 5832742
• MDR Text Key: 50717547
• Report Number: 0002134265-2016-00018
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2016
• Device Catalogue Number: M0032072415200
• Device Lot Number: 16570972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR