MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GATEWAY MR 2.5MM X 9MM - JP; CATHETER, BALLOON TYPE

Catalog Number M0032072109250

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/09/2021

Event Type  Injury  

Event Description

It was reported that during the procedure of intracranial pta (percutaneous transluminal angioplasty) left side for arteriosclerosis of middle cerebral artery (mca) , the balloon catheter could not pass through stenosis and it bent.At that time bleeding was experienced from the stenosis at (mca) middle cerebral artery.No other information is available.

Manufacturer Narrative

Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Visual/microscopic inspection: the device was kinked.Severely kinked at the proximal end.Functional test: the balloon catheter was hydrated, and no anomalies were noted to the outer surface.An attempt was not made to advance the balloon catheter through a guide catheter, as the damage noted would not allow passage.The reported event is covered in the device directions for use (dfu).The risk of the reported event is documented in the risk documentation.The event description states that the gateway could not pass through stenosis and it bent.At that time bleeding was experienced.The device was returned for analysis and the balloon catheter shaft was noted to be extensively kinked.It is probable that the balloon catheter was damaged due to the difficulty to pass through the stenosis causing the bleeding at the site of the stenosis.An assignable cause of procedural factors will be assigned to the reported patient hemorrhage, blood loss with sequelae, balloon catheter kinked/bent and device difficulty engaging target vessel and to the analyzed balloon catheter kinked/bent, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

It was reported that during the procedure of intracranial pta (percutaneous transluminal angioplasty) left side for arteriosclerosis of middle cerebral artery (mca) , the balloon catheter could not pass through stenosis and it bent.At that time bleeding was experienced from the stenosis at (mca) middle cerebral artery.No other information is available.

• Brand Name: GATEWAY MR 2.5MM X 9MM - JP
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 11270538
• MDR Text Key: 230010869
• Report Number: 3008853977-2021-00003
• 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
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: M0032072109250
• Device Lot Number: 24196929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other