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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CORVOCET COAXIAL INTRODUCER BIOPSY NEEDLE KIT

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MERIT MEDICAL SYSTEMS INC. CORVOCET COAXIAL INTRODUCER BIOPSY NEEDLE KIT Back to Search Results
Model Number 00884450333327
Device Problems Fracture (1260); Material Fragmentation (1261)
Patient Problems Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that the biopsy device broke off and the tip of the coaxial introducer remained within the patient's body during a bone biopsy. The separated portion was approx. 1 cm in length and it remained in the body. Secondary procedure is required for the remainder, although it has not been scheduled yet. The condition of the patient has not been changed after the event, except for the tip detachment itself.
 
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Brand NameCORVOCET COAXIAL INTRODUCER
Type of DeviceBIOPSY NEEDLE KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, ut
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, ut
Manufacturer Contact
bryson heaton
1600 merit parkway
south jordan, ut 
2084662
MDR Report Key10398856
MDR Text Key202695896
Report Number1721504-2020-00062
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K151373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number00884450333327
Device Catalogue NumberCORC1610/A
Device Lot NumberH1429679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/12/2020 Patient Sequence Number: 1
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