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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX, INC. / ARROW INTERNATIONAL, INC. ARROW ENDURANCE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC
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TELEFLEX, INC. / ARROW INTERNATIONAL, INC. ARROW ENDURANCE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN037859
Device Problem Break (1069)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/05/2018
Event Type  Injury  
Event Description
During the placement of an arrow endurance peripheral catheter, it was noted that the catheter appeared to have broken off inside the patient.The physician was notified.X-ray of left upper arm did not note any foreign bodies.Vein appeared to have phlebitis, and physician believed he noted fragment on ultrasound.Patient taken to the operating room for exploration and intervascular foreign body removal.No foreign body found.Patient continues to be treated for admitting diagnosis of intercerebral hemorrhage.
 
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Brand Name
ARROW ENDURANCE CATHETER
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
TELEFLEX, INC. / ARROW INTERNATIONAL, INC.
MDR Report Key8078103
MDR Text Key127898994
Report NumberMW5081359
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10801902132908
UDI-Public(01)10801902132908
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Model NumberIPN037859
Device Catalogue NumberEDC-00620
Device Lot Number14F18G0422
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/15/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age90 YR
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