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

Model Number	IPN921175
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was placed on ecmo [extracorporeal membrane oxygenation] after a vfib [ventricular fibrillation] arrest and vfib storm.Around 35 hours later, the team noted blood coming out of the ecmo reperfusion canula that was noted to be cracked around the permanent stopcock on the device.The canula needed to be removed and replaced under sterile conditions and the patient required 3 units of blood as a result of blood loss.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 24741543
• Report Number: 24741543
• Device Sequence Number: 8779843
• Product Code: DYB
• UDI-Device Identifier: 10801902201109
• UDI-Public: (01)10801902201109
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/02/2026
• Report Date (Section F): 03/03/2026

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
• Device Model Number: IPN921175
• Device Catalogue Number: CL-07624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• 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: Required Intervention; Life Threatening
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Date Report Sent to FDA: 03/03/2026