MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; INTRODUCER, CATHETER

Model Number	IPN925059
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure a flex sheath was used to access the left femoral artery, there was challenge with placing the sheath, the sheath was removed, and it was discovered that tissue from the patient's artery was left on top of the introducer.The sheath's introducer was not locking into place.A second sheath of this same type had the same lack of lock for the introducer.The patient had harm to the left iliac artery, a stent was placed to repair the damage.Two devices - same lot#.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 22122888
• Report Number: 22122888
• Device Sequence Number: 7175934
• Product Code: DYB
• UDI-Device Identifier: 10801902210415
• UDI-Public: (01)10801902210415
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/21/2025
• Report Date (Section F): 05/21/2025

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: IPN925059
• Device Catalogue Number: CL-07611
• Device Lot Number: 14F24K0031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Date Report Sent to FDA: 05/21/2025