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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW OUS 2.25MM X 9MM; CATHETER, BALLOON TYPE
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BOSTON SCIENTIFIC - MINN FG GATEWAY OTW OUS 2.25MM X 9MM; CATHETER, BALLOON TYPE Back to Search Results
Catalog Number M0032072409220
Device Problem Air Leak (1008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2017
Event Type  malfunction  
Event Description
During the balloon angioplasty of the left middle cerebral artery (mca) stenosis, it was reported that air leaked from the balloon during dilation.There were no reported clinical consequences to the patient.
 
Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was returned wrapped around itself.The guidewire used with the catheter was not returned.Visual inspection revealed that the balloon catheter was compressed at approximately 18.0cm distal to the strain relief.It was also kinked at approximately 4.5cm from its distal end.The inflation port and proximal lumen were inspected under microscopy and the inflation port shaft appeared to be perforated.The inner shaft under the manifold appeared to be perforated.There was crystallized substance (appeared to be saline) found in the catheter as well.There were no issues observed with the coating and no other anomalies were observed.During functional testing, the 0.014" demonstration guidewire and a.010" mandrel was introduced and advanced through the catheter proximal end.The guidewire and mandrel could not be passed through the catheter, a lot of friction was encountered.The balloon failed to inflate with air because of the perforation/holes in the balloon and water leaked out of the balloon during the inflation testing.The balloon could not stay inflated.The kinks and compressions found on the catheter during device analysis were determined to be a result of handling damage during the clinical procedure.Information available indicated that the device was confirmed to be in good condition prior to use and the air leak was observed during aspiration.It is likely that the found catheter shaft leak was interpreted by the user as a balloon leak.Per the device directions for use (dfu): "introduce the guidewire, flexible-end first, into the straight (back) port of the manifold.To avoid kinking, advance the guidewire slowly in small increments to the end of the balloon catheter.¿ based on the examination of the damage inside the inflation lumen (balloon port), it appears that the guidewire was inserted into the balloon port (instead of the guidewire lumen), leading to the observed and reported leak.Based on the information available, an assignable cause of use error was assigned to this event.
 
Event Description
During the balloon angioplasty of the left middle cerebral artery (mca) stenosis, it was reported that air leaked from the balloon during dilation.There were no reported clinical consequences to the patient.
 
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Brand Name
FG GATEWAY OTW OUS 2.25MM X 9MM
Type of Device
CATHETER, BALLOON TYPE
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINN
one scimed place
maple grove MN 55311
Manufacturer (Section G)
STRYKER NEUROVASCULAR-CALIF
47900 bayside parkway
fremont CA 94538
Manufacturer Contact
tara lopez
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6883195
MDR Text Key87777858
Report Number3008853977-2017-00032
Device Sequence Number1
Product Code GBA
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
H050001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Catalogue NumberM0032072409220
Device Lot Number20021092
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age69 YR
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