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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX VG; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX VG; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 10707
Medical Device Problem Code Suction Problem (2170)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/16/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a loss of aspiration occurred.An angiojet solent omni catheter and an angiojet spiroflex vg catheter were selected for a thrombectomy procedure.However, during the procedure, it was noted that the devices would not aspirate.The procedure was completed by doing a balloon angioplasty.There were no patient complications reported and the patient was fine.
 
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Brand Name
ANGIOJET SPIROFLEX VG
Common Device Name
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9652788
Report Number2134265-2020-00772
Device Sequence Number1691006
Product Code MCX
UDI-Device Identifier08714729889441
UDI-Public08714729889441
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K080806
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/16/2021
Device Model Number10707
Device Catalogue Number10707
Device Lot Number0024640922
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/16/2020
Initial Report FDA Received Date01/31/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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