MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	IPN036455
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of catheter is getting stripped.Potential for vascular damage.8.5 french, 20 cm., 0.032 inch diameter spring wire guide.

• Brand Name: ARROW
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 8944487
• Report Number: 8944487
• Device Sequence Number: 11393177
• Product Code: FOZ
• UDI-Device Identifier: 30801902117275
• UDI-Public: (01)30801902117275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019
• Report Date (Section F): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN036455
• Device Catalogue Number: CDC-45854-P1A
• Device Lot Number: 13F19C0497
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/25/2019