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

Catalog Number	CL-07745
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: when inserting a guiding catheter into the sheath, it got stuck in the middle of the sheath.Therefore, the sheath was removed and replaced to complete the procedure.No injury to the patient occurred.No abnormality was found on the sheath before use.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: when inserting a guiding catheter into the sheath, it got stuck in the middle of the sheath.Therefore, the sheath was removed and replaced to complete the procedure.No injury to the patient occurred.No abnormality was found on the sheath before use.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, 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.
Additional Manufacturer Narrative
Qn# (b)(4).In section d provided the full udi # **udi related data quality updates only**.
Event or Problem Description
It was reported that: when inserting a guiding catheter into the sheath, it got stuck in the middle of the sheath.Therefore, the sheath was removed and replaced to complete the procedure.No injury to the patient occurred.No abnormality was found on the sheath before use.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18011483
• Report Number: 9680794-2023-00807
• Device Sequence Number: 20700385
• Product Code: DQY
• UDI-Device Identifier: 00801902001931
• UDI-Public: (01)00801902001931(11)220427(17)270331(10)14F22D0003(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2023

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-07745
• Device Lot Number: 14F22D0003
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 11/21/2023; Not provided
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/22/2023; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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; NOT REPORTED
• Patient Sex: Unknown