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U.S. Department of Health and Human Services

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

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TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device 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 per the rt the dilator was kinked upon removal from package. The event occurred pre-treatment.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1 to provide the completed investigation. One 5fr ik precision device was received for product evaluation. The device was returned with the guidewire, needle dilator and sheath. After decontamination, the returned components were subjected to visual analysis. There was an apparent kink in the dilator approximately 36. 04mm from the distal tip of the dilator. The kink in the material appeared smooth. No other gross anomalies were noted with the other returned components. There is no evidence that this event was related to a device defect or malfunction. The exact cause of the reported event cannot be definitively determined based on the available information.
 
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Brand NamePINNACLE PRECISION ACCESS SYSTEM
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
terry callahan
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key7369816
MDR Text Key103804446
Report Number1118880-2018-00014
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00389701010885
UDI-Public00389701010885
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberN/A
Device Catalogue Number70-5165
Device Lot NumberVM25
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2017
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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