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

Catalog Number	CL-07524
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during the procedure according to ifu, md the tip of the sheath to be bent.So md opened up the new kit to finish the procedure.There was no reported patient harm or consequence.They were reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The report of a bent sheath was confirmed through complaint investigation of the returned sample.The customer returned one, opened cath-lab kit for analysis.No definite signs-of-use were observed.Visual analysis of the returned sheath revealed slight bending adjacent to the distal tip.Microscopic examination confirmed the damage.It was noted that the coil wrapping at the location of the bend were slightly angled.No other imprints or divots were noted.The location within the tray that houses the defective area did not show any damage or anomalies that can contribute to this damage.The bending measured 10mm via calibrated ruler from the distal tip.The sheath length measured 9 7/16" via calibrated ruler, which was within the specification limits of 8 7/8"- 9 3/4" per the sheath product drawing.The sheath outer diameter measured 0.1025" via calibrated caliper, which was within the specification limits of 0.0990"-0.1030" per the sheath wrapped extrusion product drawing.The manufacturing unit confirmed that there is a possibility this damage can occur during packaging as the dilator is removed from the sheath during the process; however, further analysis needs to be performed to confirm this.Additionally, the ifu provided with the kit informs the user, "do not use if package is damaged".A device history record review was performed with no relevant findings.Based on the customer report, the sample received, and the comments from the manufacturing/packaging facility, packaging likely caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: during the procdeure according to ifu, md the tip of the sheath to be bent.So md opend up the new kit to finish the procedure.There was no reported patient harm or consequence.They were reported as fine.

• Brand Name: ARROW 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: 18536074
• Report Number: 9680794-2024-00004
• Device Sequence Number: 15136464
• Product Code: DQY
• UDI-Device Identifier: 00801902001771
• UDI-Public: 00801902001771
• 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): 12/27/2023

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: CL-07524
• Device Lot Number: 14F22D0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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