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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. - PEARLAND HEARTSPAN; CARDIAC TROCAR
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MERIT MEDICAL SYSTEMS, INC. - PEARLAND HEARTSPAN; CARDIAC TROCAR Back to Search Results
Model Number 00884450412862
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Tamponade (2226); Needle Stick/Puncture (2462)
Event Date 04/08/2021
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 after use of the merit heartspan transseptal needle, patient began to decompensate due to cardiac tamponade confirmed with thoracic echography.Patient was taken to cardiac surgery where a hole between the svc and ra was successfully closed.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.
 
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Brand Name
HEARTSPAN
Type of Device
CARDIAC TROCAR
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC. - PEARLAND
14646 kirby drive
houston TX 77047
MDR Report Key11962111
MDR Text Key255125101
Report Number3010665433-2021-00039
Device Sequence Number1
Product Code DRC
UDI-Device Identifier00884450412862
UDI-Public00884450412862
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/28/2023
Device Model Number00884450412862
Device Catalogue NumberFND-019-02/A
Device Lot NumberE1993216
Was Device Available for Evaluation? No
Date Manufacturer Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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