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

Catalog Number	CL-07045
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: incident occured on (b)(6) 2024.The cap broke off.The device was kept but not the cap, which was discarded.Immediate action: change device patient impact: none the returned device showed that the dilator hub separated from the device.
Additional Manufacturer Narrative
(b)(4).The customer report of a separated dilator hub was confirmed through complaint investigation of the returned sample.The customer provided two images showing a psi sheath/dilator assembly.The first image shows what appears to be the defective sample as visual analysis revealed that the dilator body was missing the hub.The severed hub is not pictured.The second image shows a reference graphic that points to the location of the observed damage.The customer returned one, psi sheath/dilator assembly and lidstock.The dilator was returned advanced through the psi sheath.Slight traces of biological material were observed on the dilator body.Visual analysis revealed that the dilator body was separated.The separated portion (includes hub) was not returned for analysis.The separation point on the dilator body were rough and discoloured.No other defects or anomalies were observed.Visual inspection of the separated dilator hub could not be performed to determine the nature of the break as it was not returned.The material at the point of separation showed white discoloration consistent to that of a stress-related break, however, the nature of the separation could not be confirmed without the hub returned for analysis.A device history record review was performed, and no relevant findings were identified.Based on these circumstances, and without the complete sample returned for analysis, the probable root cause could not be confirmed.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: incident occured on (b)(6) 2024.The cap broke off.The device was kept but not the cap, which was discarded.Immediate action: change device patient impact: none the returned device showed that the dilator hub separated from the device.

• 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: 18709932
• Report Number: 9680794-2024-00187
• Device Sequence Number: 7186848
• Product Code: DQY
• UDI-Device Identifier: 00801902001719
• UDI-Public: 00801902001719
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 01/22/2024

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-07045
• Device Lot Number: 14F23G0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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
• Patient Sex: Unknown