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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HEARTSPAN-TRANSSEPTAL NEEDLE KIT

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MERIT MEDICAL SYSTEMS INC. HEARTSPAN-TRANSSEPTAL NEEDLE KIT Back to Search Results
Model Number 00884450263181
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Cardiac Tamponade (2226); Decreased Respiratory Rate (2485); Low Cardiac Output (2501); Blood Loss (2597)
Event Date 03/17/2020
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 during a difficult transseptal puncture to complete an ablation procedure, a pericardial effusion occurred. The physician had acquired access through the fossa ovalis and into the left atrium with a coronary sinus catheter attempting to effectively map the left atrium for this patient. After a few seconds of use, the catheter would not deflect as intended. The catheter was replaced, and the procedure was continued. After mapping the left atrium, the patient became hypotensive. Ultrasound confirmed a pericardial effusion. A pericardiocentesis was performed to stabilize the patient and the procedure was discontinued. The physician alleged the effusion occurred during the transseptal puncture procedure. The physician attempted several times to acquire access with the needle which resulted in the effusion.
 
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Brand NameHEARTSPAN-TRANSSEPTAL NEEDLE KIT
Type of DeviceTRANSSEPTAL NEEDLE
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
65 great valley parkway
malvern, pa
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS INC.
65 great valley parkway
malvern, pa
Manufacturer Contact
david lockridge
1600 merit parkway
south jordan, ut 
2084551
MDR Report Key9973603
MDR Text Key190648990
Report Number2529252-2020-00006
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00884450263181
UDI-Public00884450263181
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
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 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number00884450263181
Device Catalogue NumberFND-020-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/17/2020 Patient Sequence Number: 1
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