MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC ARROW; INTRODUCER, CATHETER

Model Number	IPN000134
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor was in the process of upsizing a 5fr sheath to a 6-11 arrow sheath in the left common femoral artery.While attempting to insert the sheath into left common femoral artery, the sheath broke.This resulted in the patient having exsanguination from the common femoral artery and receiving 2 units of packed red blood cells, along with an emergent cut down procedure to the left groin to extract the broken sheath.Vascular surgery was overhead paged stat and responded.Hemostasis was achieved by the physician in the room by upsizing the sheath to a 9 fr cordis-brite tip sheath.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC; 2400 bernville road; reading PA 19605
• MDR Report Key: 7560767
• Report Number: 7560767
• Device Sequence Number: 1755084
• Product Code: DYB
• UDI-Device Identifier: 00801902001818
• UDI-Public: (01)00801902001818
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2018
• Report Date (Section F): 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Model Number: IPN000134
• Device Catalogue Number: CL-07611
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 80 YR
• Date Report Sent to FDA: 05/23/2018