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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 10706
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event or Problem Description
It was reported that catheter stuck on wire occurred.An angiojet spiroflex catheter was selected for use.During advancing, it was noted that the catheter would not advance over a non-bsc wire and was trapped.The device never entered the patient.No patient complications were reported.
 
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Brand Name
ANGIOJET SPIROFLEX
Common Device Name
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12232248
Report Number2134265-2021-09549
Device Sequence Number3668426
Product Code MCX
UDI-Device Identifier08714729889380
UDI-Public08714729889380
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K072769
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
Type of Report Initial
Report Date (Section B) 07/27/2021
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 Date02/16/2022
Device Model Number10706
Device Catalogue Number10706
Device Lot Number0025458174
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/06/2021
Initial Report FDA Received Date07/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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