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 Problem Hemorrhage, Subarachnoid (1893)

Event Date 05/04/2015

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported in a post marketing surveillance report that a subarachnoid hemorrhage (sah) occurred in the treated lesion during the procedure.The target lesion was left m1 distal.Thrombus aspiration was performed with an aspiration catheter but it did not work.Two passes with a retrieval system were then performed and angioplasty was done 3 times with a balloon (subject device).Reperfusion was achieved but the sah occurred in the treated area.No medical treatment was performed for the sah as it was not serious.

Manufacturer Narrative

A device history record review could not be performed as the lot number of the device is unknown.The device was not returned for analysis therefore visual inspection and functional testing could not 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.Hemorrhage is a known and anticipated complications to these types of procedures and is noted in the labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.

Event Description

It was reported in a post marketing surveillance report that a subarachnoid hemorrhage (sah) occurred in the treated lesion during the procedure.The target lesion was left m1 distal.Thrombus aspiration was performed with an aspiration catheter but it did not work.Two passes with a retrieval system were then performed and angioplasty was done 3 times with a balloon (subject device).Reperfusion was achieved but the sah occurred in the treated area.No medical treatment was performed for the sah as it was not serious.

• 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: 5049441
• MDR Text Key: 24828535
• Report Number: 3008853977-2015-00368
• 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: Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 10/13/2015
• 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): Other
• Patient Age: 88 YR