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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GATEWAY OTW 2.0MM X 9MM - CE; CATHETER, BALLOON TYPE
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BOSTON SCIENTIFIC - MINN GATEWAY OTW 2.0MM X 9MM - CE; CATHETER, BALLOON TYPE Back to Search Results
Catalog Number M0032072409200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Paralysis (1997); Vasoconstriction (2126); Obstruction/Occlusion (2422); Vascular Dissection (3160)
Event Date 08/16/2022
Event Type  Injury  
Event Description
Prior procedure, the patient presented with numbness of one limb.The subject gateway balloon was used to dilate.After dilating, the subject gateway balloon was withdrawn, a dissection occurred (the vessel was found thin) under radiography in the mca (middle cerebral artery) m1 near bifurcation of m2 and the cause of the dissection was unknown.According to the physician, the dissection might be related to the subject gateway balloon device, but it¿s not for certain.The neuroform atlas stents were used as medical intervention to solve and caused a 120-minute surgical delay.However, the effect was not good enough and the mca was still occluded.Post procedure, the patient delayed for analepsia and one side of the body had hemiplegia symptom possibly related to the stents.Hemiplegia last for three days, but muscle strength still decreased.The patient current condition is getting better.
 
Manufacturer Narrative
This is 4 of 4 reports (4th mdr).The device is not available to the manufacturer.
 
Event Description
Prior procedure, the patient presented with numbness of one limb.The subject gateway balloon was used to dilate.After dilating, the subject gateway balloon was withdrawn, a dissection occurred (the vessel was found thin) under radiography in the mca (middle cerebral artery) m1 near bifurcation of m2 and the cause of the dissection was unknown.According to the physician, the dissection might be related to the subject gateway balloon device, but it¿s not for certain.The neuroform atlas stents were used as medical intervention to solve and caused a 120-minute surgical delay.However, the effect was not good enough and the mca was still occluded.Post procedure, the patient delayed for analepsia and one side of the body had hemiplegia symptom possibly related to the stents.Hemiplegia last for three days, but muscle strength still decreased.The patient current condition is getting better.
 
Manufacturer Narrative
This is 4 of 4 reports (4th mdr).H4 manufacturing date ¿ added.D4 expiration date - added.D4 catalog # ¿ corrected.D4 lot # - corrected.D1 product long description ¿ updated.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).It cannot be confirmed if the device met specification, as the device was not returned.It was reported that the operator deployed the first stent (3mm*21) and after the deployment, the vessel was occluded and the proximal of the vessel had spasm.The operator continued to deploy 4.5mm*21mm and 4.5mm*30mm stents, but the mca was still occluded.After the procedure, the patient delayed for analepsia and one side of the body had hemiplegia symptom.The risk of the reported events is documented in the dfu, as potential adverse events which can occur during these types of procedures, therefore an assignable cause of anticipated procedural complication, will be assigned to the reported ¿patient vessel dissection¿, ¿patient stroke¿, ¿patient vasospasm serious¿ and ¿patient vessel occlusion.¿.
 
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Brand Name
GATEWAY OTW 2.0MM X 9MM - CE
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
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key15435757
MDR Text Key300033381
Report Number3008853977-2022-00045
Device Sequence Number1
Product Code GBA
Combination Product (y/n)N
Reporter Country CodeCH
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 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberM0032072409200
Device Lot Number28158178
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
THREE ATLAS STENTS (STRYKER)
Patient Outcome(s) Required Intervention; Other;
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