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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 Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Patient identifier - requested, not provided. Age & date of birth - requested, not provided. Weight - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Date of event: requested, not provided. Lot #: requested, not provided. Expiration date - unknown due to unknown lot number. Udi - unknown due to unknown lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown 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. For this reason, evaluation code has been referenced in the conclusions section. 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 during a peripheral vascular case they had a dilator tip break off in the patient. They had to search and remove the detached piece. The procedure outcome was fine, and it was reported the patient's condition was fine. Numerous items were used with the device since it was a peripheral vascular case. Additional information was received on march 2, 2018. The broken tip was retrieved from the patient.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1 to provide the completed investigation. The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. With no device return 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 Key7381913
MDR Text Key103844842
Report Number1118880-2018-00015
Device Sequence Number1
Product Code DYB
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 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number70-5165
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/17/2018
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: 03/29/2018 Patient Sequence Number: 1
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