MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH LAB SHEATH INTRO SET; CATHETER PERCUTENEOUS

Catalog Number	CP-07511
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported that: the sheath body was found bent upon opening the package.Therefore, a new kit was used instead.
Event or Problem Description
It was reported that: the sheath body was found bent upon opening the package.Therefore, a new kit was used instead.
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cath-lab sheath introducer kit for analysis.No signs of use were observed on the returned components.Visual inspection revealed that the sheath and dilator were kinked and deformed in several locations.The tray was observed to be damaged in multiple locations.Packaging r & d engineers were contacted regarding this complaint investigation.They indicated that based on the component damage and the tray damage, that the defect is likely a result of the dilator/sheath assembly coming out of its intended location within the kit due to excessive handling during shipping/transportation.A device history record review was performed with no relevant findings.The customer report of a kinked sheath was confirmed through complaint investigation of the returned sample.Visual inspection revealed the sheath/dilator assembly and kit tray were kinked and deformed in several locations.Damage to the packaging tray was also observed.The damage to the components and tray is likely a result of the dilator/sheath assembly coming out of its intended location within the kit due to excessive handling during shipping/transportation.A device history record review was performed with no relevant findings to suggest a manufacturing issue.Based on these circumstances, and the comments from packaging r & d, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # udi related data quality updates only.
Event or Problem Description
It was reported that: the sheath body was found bent upon opening the package.Therefore, a new kit was used instead.

• Brand Name: ARROW CATH LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTENEOUS
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18254697
• Report Number: 9680794-2023-00941
• Device Sequence Number: 6572179
• Product Code: DQY
• UDI-Device Identifier: 00801902002105
• UDI-Public: (01)00801902002105(11)230403(17)280229(10)14F23B0216(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2023

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 Catalogue Number: CP-07511
• Device Lot Number: 14F23B0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/20/2023; Not provided
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/27/2023; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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; NOT REPORTED
• Patient Sex: Unknown