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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 45032
Medical Device Problem Code Suction Problem (2170)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/28/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that insufficient suction occurred.An angiojet solent proxi catheter was used in a thrombectomy procedure.During procedure under thrombectomy mode, it was noted that the device was not aspirating at its usual volume and was leaking from the pump bulb.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
ANGIOJET SOLENT PROXI
Common Device Name
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11334276
Report Number2134265-2021-01742
Device Sequence Number19038382
Product Code DXE
UDI-Device Identifier08714729889595
UDI-Public08714729889595
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K101406
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/16/2021
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 Date01/06/2022
Device Model Number45032
Device Catalogue Number45032
Device Lot Number0025481301
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/28/2021
Initial Report FDA Received Date02/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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