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

Catalog Number	CL-71180
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found a kink in the sheath dilator.So the md opened up the new kit to finish the procedure".
Additional Manufacturer Narrative
Qn#(b)(4).The report that of a kinked sheath was confirmed through complaint investigation.Visual analysis revealed two major kinks along the sheath body.When inside the pouch, these kinks lined-up with crease marks on the outer pouch.Despite the damage, the sheath met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the appearance of the kinking seems consistent with damage due to improper storage/shipping; however, it is unknown if this kinking occurred before or after the pouch was stapled by the customer.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Additional Manufacturer Narrative
(b)(4).The report that of a kinked sheath was confirmed through complaint investigation.Visual analysis revealed two major kinks along the sheath body.When inside the pouch, these kinks lined-up with crease marks on the outer pouch.Despite the damage, the sheath met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the appearance of the kinking seems consistent with damage due to improper storage/shipping; however, it is unknown if this kinking occurred before or after the pouch was stapled by the customer.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found a kink in the sheath dilator.So the md opened up the new kit to finish the procedure".

• Brand Name: CATH-LAB SHEATH INTRO SET:
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 18847008
• Report Number: 9680794-2024-00145
• Device Sequence Number: 20772932
• Product Code: DQY
• UDI-Device Identifier: 00801902001757
• UDI-Public: 00801902001757
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: CL-71180
• Device Lot Number: 14F21K0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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: Unknown