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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 Codes Leak/Splash (1354); Suction Problem (2170)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/17/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that loss of aspiration occurred.An angiojet solent proxi catheter was used for thrombectomy procedure.During the procedure, the device did not continue to infuse saline when aspiration was lost during thrombectomy mode.The procedure was completed with another of same 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 Key12139903
Report Number2134265-2021-08579
Device Sequence Number17188546
Product Code DXE
UDI-Device Identifier08714729889595
UDI-Public08714729889595
Combination Product (Y/N)N
Initial Reporter StateMN
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/08/2021
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 Date01/20/2023
Device Model Number45032
Device Catalogue Number45032
Device Lot Number0026977988
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/18/2021
Initial Report FDA Received Date07/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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