MAUDE Adverse Event Report: TELEFLEX, INC. / ARROW INTERNATIONAL INC. ARROW ENDURANCE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS

Model Number	IPN037860
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Peripheral iv placed via ultrasound using a technique called accelerated seldinger(ast).The nurse retracted the device by grasping the catheter pulling it back over the needle approximately 0.5 cm.On inspection of the device 0.5 cm was missing from the end of the catheter.Unable to visually determine if it fell on the bed on removal, the rn responded immediately notifying the nurse manager for direction.They physician was notified and x-rays were ordered as recommended.The medical director was notified and collaborated with the care and treatment recommendations.The foreign body was identified in the soft tissue vs the vessel, via x-ray of arm.Chest x-ray was negative for foreign body.A ct scan was done to further define the location of the catheter tip.The patient was made npo for local anesthetic removal in operating room.Patient tolerated the removal procedure and was discharged to home in stable condition the following day.

• Brand Name: ARROW ENDURANCE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX, INC. / ARROW INTERNATIONAL INC. ; reading PA 19605
• MDR Report Key: 8194434
• Report Number: MW5082553
• Device Sequence Number: 16192287
• Product Code: FOZ
• UDI-Device Identifier: 10801902132922
• UDI-Public: (01)10801902132922
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: IPN037860
• Device Catalogue Number: EDC-00622
• Device Lot Number: 14F18H0262
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 77