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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE SHORT SHEATH INTRODUCER

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MERIT MEDICAL SYSTEMS INC. PRELUDE SHORT SHEATH INTRODUCER Back to Search Results
Catalog Number PSS-6F-4MT
Device Problems Fracture (1260); Material Separation (1562)
Patient Problems Non specific EKG/ECG Changes (1817); Foreign Body In Patient (2687)
Event Date 08/21/2018
Event Type  Injury  
Manufacturer Narrative
The suspect device is not expected to return for evaluation. A review of the device history and complaint database could not be performed since the lot number was not provided.
 
Event Description
The account alleges that post av fistula gram procedure, the hub of the sheath detached leaving the remainder of the sheath within the patient. The physician states that fluoroscopy confirmed that the remainder of the sheath was migrating to the patient's subclavian and possibly the pulmonary artery [pa]. The physician was about to attempt a foreign body retrieval from the patient via vascular snare device but, by the time the vascular snare device was inserted into the patient the sheath had already migrated into the patient's right ventricle. The physician states that the patient started experiencing ecg changes and that the event was life threatening. The patient was quickly prepped and transferred to a sister hospital and was admitted to the surgical center for emergent sternotomy for foreign object removal from the patient's right ventricle.
 
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Brand NamePRELUDE SHORT SHEATH INTRODUCER
Type of DeviceINTRODUCER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, UT 84095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, UT 84095
Manufacturer Contact
katie swenson cqe,cba,cqpa.
1600 merit parkway
south jordan, UT 84095
8012531600
MDR Report Key7837400
MDR Text Key118910219
Report Number1721504-2018-00089
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPSS-6F-4MT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
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 Treatment Data
Date Received: 08/31/2018 Patient Sequence Number: 1
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