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

Catalog Number M0032072415200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Infarction, Cerebral (1771); Death (1802); Hemorrhage, Cerebral (1889)

Event Date 01/14/2014

Event Type  Death  

Event Description

It was reported that a patient presented with 72% stenosis in the right m1 middle cerebral artery (mca).The subject device was advanced into the stenosed lesion and inflated to 6 atm.The device was removed and the stenosis was not improved.The device was readvanced and reinflated to 8 atm.The stenosis seemed to be improved under angiography and the device was removed.However, the ct-scan showed a hemorrhage.The hemorrhage resulted in a stroke.The patient was treated with aspirin, lipitor and liusuanqinglupigelei pian.One day post procedure the patient passed away.

Manufacturer Narrative

Device was disposed.

Event Description

It was reported that a patient presented with 72% stenosis in the right m1 middle cerebral artery (mca).The subject device was advanced into the stenosed lesion and inflated to 6 atm.The device was removed and the stenosis was not improved.The device was readvanced and reinflated to 8 atm.The stenosis seemed to be improved under angiography and the device was removed.However, the ct-scan showed a hemorrhage.The hemorrhage resulted in a stroke.The patient was treated with aspirin, lipitor and liusuanqinglupigelei pian.One day post procedure the patient passed away.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The device was not returned; therefore, 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.Patient hemorrhage, stroke and death are known and anticipated complications to these types of procedures and are noted in the labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.

• 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: alyson harris ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 3601524
• MDR Text Key: 4088752
• Report Number: 3008853977-2014-00034
• Device Sequence Number: 1
• Product Code: PAV
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/14/2014

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 Catalogue Number: M0032072415200
• Device Lot Number: 16177380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 01/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: EXCELSIOR MICROCATHETER (STRYKER); SYNCHRO 300 GUIDEWIRE (STRYKER)
• Patient Outcome(s): Death
• Patient Age: 69 YR