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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLENT PROXI; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION SOLENT PROXI; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 109676
Device Problems Failure to Prime (1492); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2018
Event Type  malfunction  
Event Description
Angiojet ultra solent proxi 6fr catheter lot#21776170 didn't complete prep via the angiojet machine (didn't prime).After a couple of attempts to prep the proxi the team discarded the device from the tray.A second device was pulled (lot# 19776365) the second device completed the prep without issue.However, once placed in the body it quit working.The third device worked without issue.They were both completed by the lead radiology tech per site reporter: i spoke to the complaints department and they are sending me shipping material.
 
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Brand Name
SOLENT PROXI
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key7537293
MDR Text Key109039621
Report Number7537293
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date07/31/2018
Device Model Number109676
Device Catalogue Number109676
Device Lot Number19776365
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2018
Event Location Hospital
Date Report to Manufacturer05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; NO OTHER THERAPIES
Patient Age18 YR
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