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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC MERIT CUSTOM KIT

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MERIT MEDICAL SYSTEMS, INC MERIT CUSTOM KIT Back to Search Results
Catalog Number K09-02334N
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2016
Event Type  Injury  
Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause is unknown.A review of the complaint database and device history record could not be performed since the lot number was not provided.
 
Event Description
The user reported that the purchased drip chamber in their kit is running out of contrast before the contrast bottle is empty.Post procedure review of the coronary angiograms confirmed that air was injected into one of the coronary arteries.The patient had no symptoms and did not require treatment.
 
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Brand Name
MERIT CUSTOM KIT
Type of Device
CUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC
1600 west merit parkway
south jordan UT 84095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS, INC
1600 west merit parkway
south jordan UT 84095
Manufacturer Contact
casey hughes, ms, cqe
1600 west merit parkway
south jordan, UT 84095
8013164932
MDR Report Key5913519
MDR Text Key53458430
Report Number1721504-2016-00170
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K913161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Remedial Action Recall
Type of Report Initial
Report Date 08/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberK09-02334N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2016
Initial Date FDA Received08/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Life Threatening;
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