MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Model Number	IPN032907
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reports concern with clear labeling of outer dimension of the mac proximal line on packaging.It was reported "they believe the 9f on the packaging is misleading as they think the proximal is a lot larger".Customer reports "patient had a potential s.I.(serious incident) due to the large wound being left and is now going to be on life-long anti-platelets".It was reported this may have been due to inadvertent cannulation.Additional information was requested but was not available at the time of this report.
Event or Problem Description
Customer reports concern with clear labeling of outer dimension of the mac proximal line on packaging.It was reported "they believe the 9f on the packaging is misleading as they think the proximal is a lot larger".Customer reports "patient had a potential s.I.(serious incident) due to the large wound being left and is now going to be on life-long anti-platelets".It was reported this may have been due to inadvertent cannulation.Additional information was requested but was not available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The customer report of incorrect labeling of the product could not be confirmed through evaluation of the available information.The customer stated that there was no description or information clearly labelled for the outer dimension of the mac, however, the lidstock image for this product shows a cross section of the sheath body with the outer diameter specified.Complaint verification testing could not be performed to determine if the sheath met relevant requirements as no sample was returned for analysis.The lidstock provided with this kit contains an image labelled as the "device cross section" which shows a cross section of the sheath body and inner lumens.The image shows the od specification as 4.7mm and the inner lumens ids as 9fr (distal) and 12ga (proximal).A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• 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: 17199880
• Report Number: 9680794-2023-00447
• Device Sequence Number: 17584469
• Product Code: DYB
• UDI-Device Identifier: 10801902024418
• UDI-Public: 10801902024418
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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
• Device Model Number: IPN032907
• Device Catalogue Number: CA-11142
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female