MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY MR JP 2.00MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072109200

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

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Vascular Dissection (3160)

Event Date 06/01/2011

Event Type  Death  

Manufacturer Narrative

The subject device was disposed of at the hospital.

Event Description

It was reported that during percutaneous transluminal angioplasty (pta) with the balloon catheter (subject device), middle cerebral artery dissection and bleeding occurred.No additional treatment was performed and the patient later died.No further information is available.

Manufacturer Narrative

The device history record review was unable to be performed as the lot number of the device was not reported.The subject device is not available; therefore, analysis cannot be performed.From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse.There is also no indication that the subject device malfunctioned.However, death, vessel dissection and hemorrhage are known risks associated with such procedures and noted as such in the directions for use (dfu).Therefore, a root cause of anticipated procedural complications has been assigned to the event.

Event Description

It was reported that during percutaneous transluminal angioplasty (pta) with the balloon catheter (subject device), middle cerebral artery dissection and bleeding occurred.No additional treatment was performed and the patient later died.No further information is available.

• Brand Name: FG GATEWAY MR JP 2.00MM X 9MM
• 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5336125
• MDR Text Key: 34708896
• Report Number: 3008853977-2015-00549
• Device Sequence Number: 0
• Product Code: PAV
• 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: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0032072109200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• 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
• Patient Outcome(s): Death; Other
• Patient Age: 61 YR