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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 Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.The device was received with an unknown guidewire and a 6fr introducer sheath.Inspection of the device revealed a shaft kink as well as tip damage on the introducer sheath; however, the kink did not disrupt functional testing of the device.Catheter tip passed through introducer sheath with only slight resistance due to the shaft kink.The complaint was confirmed for shaft damage which could have contributed to the reported event.
 
Event Description
It was reported that there was difficulty removing the device.The target lesion was located in the av access.An angiojet solent omni was advanced for treatment.During the procedure, the device could not be removed from sheath.The procedure was completed with another of the same device.No complications were reported.
 
Event Description
It was reported that there was difficulty removing the device.The target lesion was located in the av access.An angiojet solent omni was advanced for treatment.During the procedure, the device could not be removed from sheath.The procedure was completed with another of the same device.No complications were reported.It was further reported that thrombectomy was completed at the time of occurrence.The device and sheath were not removed together; the defective product was never inserted through the sheath.Instead, it was replaced directly with a new one to complete the procedure.No damage was observed on the device.However, during priming of the catheter, an error message "check saline supply" was displayed.The user then switched to another catheter for priming and successfully completed the procedure without any issues.
 
Manufacturer Narrative
Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.The device was received with an unknown guidewire and a 6fr introducer sheath.Inspection of the device revealed a shaft kink as well as tip damage on the introducer sheath; however, the kink did not disrupt functional testing of the device.Catheter tip passed through introducer sheath with only slight resistance due to the shaft kink.The complaint was confirmed for shaft damage which could have contributed to the reported event.
 
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Brand Name
ANGIOJET SOLENT OMNI
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18941579
MDR Text Key338345124
Report Number2124215-2024-16254
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number45031
Device Catalogue Number45031
Device Lot Number0031784100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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