MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; WIRE, GUIDE, CATHETER

Model Number	IPN921746
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While the arterial line was being placed, resistance was encountered as the guidewire was inserted.The guidewire then could not be removed.Thus, both the needle and guidewire ended up being removed as a unit, which likely contributed to the hematoma.Once out of the body, the resident noticed that the tip of the guidewire appeared frayed.Eventually they separated the guidewire and the needle apparatus, at which point the guidewire tip had unraveled and more extensively frayed.It was described as having an appearance of a spiral cat toy.Manufacturer response for wire, guide, catheter, arrow (per site reporter).Device was returned to the manufacturer.

• Brand Name: ARROW
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 17763791
• Report Number: 17763791
• Device Sequence Number: 12536234
• Product Code: DQX
• UDI-Device Identifier: 10801902200447
• UDI-Public: (01)10801902200447
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/08/2023
• Report Date (Section F): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN921746
• Device Catalogue Number: ASK-04120-HF3
• Device Lot Number: 33F23E0480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 09/08/2023