MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 2-L: 5.5FR X 15CM; INTRODUCER CATHETER

Model Number	IPN923012
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported kinking of introducer/glide thru sheath.No patient harm was reported.A new sheath was used.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of damaged/defective peel-away body was confirmed by visual inspection of the customer supplied photos.However, full complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "check peel-away sheath placement by holding sheath in place, twisting dilator hub counterclockwise to release dilator hub from sheath hub, withdraw guidewire and dilator sufficiently to allow blood flow".A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported kinking of introducer/glide thru sheath.No patient harm was reported.A new sheath was used.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PI MIDLINE 2-L: 5.5FR X 15CM
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17321676
• Report Number: 9680794-2023-00516
• Device Sequence Number: 20561040
• Product Code: DYB
• UDI-Device Identifier: 10801902205428
• UDI-Public: 10801902205428
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K122854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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
• Device Expiration Date: 03/31/2024
• Device Model Number: IPN923012
• Device Catalogue Number: CDC-41552-MPKB
• Device Lot Number: 33F23B0837
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Female