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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
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2023
Event Type  malfunction  
Event Description
It was reported that device was contaminated.An angiojet spiroflex catheter was selected for left heart catheterization procedure.Upon opening the product, it was noticed that the device was leaking through the sterile package.No patient complications reported.
 
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Brand Name
ANGIOJET SPIROFLEX
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16619399
MDR Text Key312049067
Report Number2124215-2023-13457
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729889380
UDI-Public08714729889380
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/27/2023
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
Device Operator Health Professional
Device Model Number10706
Device Catalogue Number10706
Device Lot Number0030659778
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/02/2023
Initial Date FDA Received03/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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