MAUDE Adverse Event Report: ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V. ARROW SINGLE-LUMEN INFUSION CATHETER (SLIC); INTRODUCER, CATHETER

Model Number	IPN039999
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Through several review, an identified trend with single lumen infusion catheter and intraoperative complication - device had perforated junction of the superior vena cava and the innominate vein.This was repaired during the surgery and line was removed.Determined that this device type is no longer used by anesthesia group.Fda safety report id # (b)(4).

• Brand Name: ARROW SINGLE-LUMEN INFUSION CATHETER (SLIC)
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V.; MX
• MDR Report Key: 14676472
• Report Number: MW5110264
• Device Sequence Number: 5388534
• Product Code: DYB
• UDI-Device Identifier: 10801902148091
• UDI-Public: (01)10801902148091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: IPN039999
• Device Catalogue Number: SC-14701
• Device Lot Number: 14F19K0503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2022
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White