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

Catalog Number	CL-07624
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "during the procedure according to ifu, the md found tip of the dilator to be bent.So the md opend up the new kit to finish the procedure." no patient harm or injury.No medical intervention required.The pateint's current condition is reported as "fine".
Event or Problem Description
It was reported "during the procedure according to ifu, the md found tip of the dilator to be bent.So the md opened up the new kit to finish the procedure." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4), the customer returned one opened cath-lab sheath introducer set for evaluation.Signs-of-use were observed on the returned components.Visual inspection of the dilator tip was split and frayed.The damage appears consistent with undue force applied to the dilator during an attempted insertion.The dilator total length measured 13" which is within the specifications of 12 1/2"-13 1/4" per product drawing.The dilator inner diameter at the tip could not be accurately measured due to the damage.Functional inspection of the dilator was performed per the instructions-for-use (ifu) provided with the kit, which states "ensure dilator hub fully snaps into sheath cap." the dilator was able to fully thread into the sheath with no resistance.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary." the customer report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual inspection revealed the dilator tip was frayed.The damage appears consistent with undue force being applied to the dilator during an attempted insertion.The returned dilator met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19164010
• Report Number: 9680794-2024-00359
• Device Sequence Number: 17967893
• Product Code: DQY
• UDI-Device Identifier: 00801902001825
• UDI-Public: 00801902001825
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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
• Device Catalogue Number: CL-07624
• Device Lot Number: 14F23F0264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown