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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION (TMC) R2P DEST SLENDER 119CM6FR STR INTRODUCER, CATHETER

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TERUMO MEDICAL CORPORATION (TMC) R2P DEST SLENDER 119CM6FR STR INTRODUCER, CATHETER Back to Search Results
Model Number GS-R6ST1C12W
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/05/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device has not been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. A review of the device history record of the product code/lot# combination was conducted with no findings.
 
Event Description
The user facility reported that the r2p destination sl guiding sheath was inserted from the right radial artery. When the manipulation of the catheter was almost completed in endovascular treatment (evt), blood leakage was observed from a kinked part in the shaft. The guiding sheath was used to complete the procedure and the procedure was completed successfully. There was no health damage to the patient. The estimated blood loss was less than 250ccs. There was no patient injury, medical/surgical intervention required. There were no other devices or equipment used with the reported product.
 
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Brand NameR2P DEST SLENDER 119CM6FR STR
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION (TMC)
950 elkton blvd.
elkton MD 21921
Manufacturer (Section G)
TERUMO MEDICAL CORPOTATION
950 elkton blvd
elkton MD 21921
Manufacturer Contact
mary o'neill
950 elkton blvd
elkton, MD 21921
8002837866
MDR Report Key11365506
MDR Text Key233092381
Report Number1118880-2021-00023
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00389701011547
UDI-Public(01)00389701011547(17)220630(10)YA22
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K193125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Model NumberGS-R6ST1C12W
Device Catalogue NumberGS-R6ST1C12W
Device Lot NumberYA22
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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