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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE INTRODUCER, CATHETER

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TERUMO MEDICAL CORPORATION PINNACLE INTRODUCER, CATHETER Back to Search Results
Model Number RSS501
Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 08/13/2021
Event Type  malfunction  
Event Description
5fr terumo pinnacle sheath (ref# rss501, lot# 000003555): used for a mesenteric angio for y90 (yttrium-90) planning, the stopcock holes on the sheath are not in the correct spots, allowed air into sheath. Manufacturer error. Sheath was inserted into patient, defect was identified upon flushing, sheath had to be removed from patient and a new sheath opened.
 
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Brand NamePINNACLE
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd
elkton MD 21921
MDR Report Key12391404
MDR Text Key268922877
Report Number12391404
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRSS501
Device Catalogue NumberRSS501
Device Lot Number000003555
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2021
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer08/31/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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