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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45031
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 11/12/2019
Event Type  malfunction  
Event Description
It was reported that during unpacking a catheter shaft fracture was observed.A solent omni thrombectomy catheter was unpacked and it was observed that the catheter had a shaft fracture.The procedure was completed with another of same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the solent omni thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Fluid was present inside the boot and device, indicating that the device was prepped not just unpackaged, as reported.Visual inspection of the device revealed that there were numerous kinks through the catheter shaft with outer shaft partially detached with the hypotube broken and protruding through the outer shaft 49.5cm distal of the strain relief.The hypotube was broken with the separated ends being ovaled, indicating that the hypotube was kinked prior to separation.
 
Event Description
It was reported that during unpacking a catheter shaft fracture was observed.A solent omni thrombectomy catheter was unpacked and it was observed that the catheter had a shaft fracture.The procedure was completed with another of same device.There were no patient complications reported.
 
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Brand Name
ANGIOJET SOLENT OMNI
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9418704
MDR Text Key172067546
Report Number2134265-2019-15102
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
PMA/PMN Number
K111182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/02/2020
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 Expiration Date07/14/2021
Device Model Number45031
Device Catalogue Number45031
Device Lot Number0024422431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2019
Initial Date Manufacturer Received 11/21/2019
Initial Date FDA Received12/05/2019
Supplement Dates Manufacturer Received12/17/2019
Supplement Dates FDA Received01/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
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