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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 Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Event Description
It was reported that sterilty was compromised.An angiojet solent omni catheter was selected for use.During preparation, it was noted that the sterile package was already opened.The product was not sent to the sterile field.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that sterilty was compromised.An angiojet solent omni catheter was selected for use.During preparation, it was noted that the sterile package was already opened.The product was not sent to the sterile field.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the product return contained an angiojet solent omni.The device was returned inside of the packaging, with the white strip that indicates a sealed back missing.The assembly, supply line, shaft, saline supply and tip were all visually examined for potential damage.A functional test was performed.The pump was placed into the ultra drive console and the device primed with no complication.The device was run for a total time of 90 seconds in thrombectomy more.The device stayed within the expected range of the product, with an average pressure.No damage or discrepancies were noted on the rest of the catheter upon visual inspection.
 
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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 Key12413648
MDR Text Key269530789
Report Number2134265-2021-11113
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729889663
UDI-Public08714729889663
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,health
Type of Report Initial,Followup
Report Date 09/28/2021
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
Device Operator Health Professional
Device Expiration Date02/21/2023
Device Model Number45031
Device Catalogue Number45031
Device Lot Number0027231493
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Initial Date Manufacturer Received 08/16/2021
Initial Date FDA Received09/02/2021
Supplement Dates Manufacturer Received09/08/2021
Supplement Dates FDA Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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