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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION UNK R2P¿ INTRODUCER, CATHETER

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TERUMO MEDICAL CORPORATION UNK R2P¿ INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Memory Loss/Impairment (1958); Occlusion (1984); Visual Impairment (2138)
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative
Expiration date - unknown due to unknown part number/lot number. Udi - unknown due to unknown part number/lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown lot number. Pma/510(k)- unknown due to unknown part number/lot number. The actual device was not returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.
 
Event Description
The user facility reported that the patient received r2p treatment for superficial femoral artery (sfa) stenosis on (b)(6) 2019. Post operation the patient presented stroke like symptoms. The patient presented with elevated blood pressure (bp) during the procedure of over 220mmhg systolic. Post operation the patient complained of headaches. Post operation day two, the patient continued to complain of severe headaches, memory loss, and vision impairment and presented to the emergency department (ed). The patient was ambulatory with no motor deficits. The patient received a computed tomography (ct) and magnetic resonance (mr), which confirmed infarct in the right occipital region. The patient has subsequently been discharged. It is also unknown if patient is asymptomatic. The procedure was outcome was successful. The patient condition is unknown.
 
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Brand NameUNK R2P¿
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
Manufacturer (Section G)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
Manufacturer Contact
theresa mussaw
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key8728618
MDR Text Key149057109
Report Number1118880-2019-00137
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2019
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: 06/24/2019 Patient Sequence Number: 1
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