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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER INTRODUCER, CATHETER

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TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER INTRODUCER, CATHETER Back to Search Results
Model Number GS-R6ST1C12W
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
Event Type  malfunction  
Event Description
Guiding sheath separated during removal. No patient harm noted.
 
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Brand NameR2P DESTINATION SLENDER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd
elkton MD 21921
MDR Report Key11100331
MDR Text Key224527131
Report Number11100331
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 Other Health Care Professional
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGS-R6ST1C12W
Device Catalogue NumberGS-R6ST1C12W
Device Lot NumberXG04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/15/2020
Event Location No Information
Date Report to Manufacturer12/31/2020
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?
Type of Device Usage Unkown

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