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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ASAP; CATHETER, EMBOLECTOMY
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MERIT MEDICAL SYSTEMS INC. ASAP; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 00884450437261
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  Injury  
Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during an emergent procedure, an interventional guidewire became stuck within the aspiration catheter formin a loop.The physician was forced to remove all interventional equipment and make a second attempt in treating the patient.The patient tolerated the procedure well.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later date, the investigation will be re-opened.
 
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Brand Name
ASAP
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan UT 84095
MDR Report Key10897325
MDR Text Key218199315
Report Number1721504-2020-00098
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00884450437261
UDI-Public00884450437261
Combination Product (y/n)N
PMA/PMN Number
K100569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number00884450437261
Device Catalogue NumberASAP100
Was Device Available for Evaluation? No
Date Manufacturer Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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