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

Catalog Number	CL-07065
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the first package was opened and the lure lock part to the inner dilator was broken off inside the sterile packaging.The second package got opened and sheath inserted into the body and when the physician went to pull the inner dilator out of the sheath, the lure lock hub broke off".No medical intervention required.No patient harm or injury.The patient's current condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer provided three images for analysis.The images show the dilator advanced through the sheath without the hub present.Signs of use are also observed on the components.The customer also returned one sheath/dilator assembly and the product lidstock for analysis.The dilator was returned advanced through the sheath.The dilator hub was not returned.The dilator was removed from the sheath to further analyze the separation point.Visual analysis revealed that the dilator body was completely separated.The separation point was rough.The condition of the separation point appeared consistent to that of a stress related break.Visual inspection of the dilator hub separation point to determine the nature of the break could not be performed as it was not returned for analysis.No other defects or anomalies were observed.A device history record review was performed, and no relevant findings were identified.The customer report of a dilator hub separation was confirmed through complaint investigation of the returned sample.The dilator was separated directly adjacent to the hub, however, the separated hub was not returned for evaluation.The appearance of the point of separation appeared consistent to that of a stress related break, however, without the separated hub returned the nature of the break could not be determined.A device history record review was performed with no relevant findings.Based on these circumstances, and without the complete sample returned for analysis, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "the first package was opened and the lure lock part to the inner dilator was broken off inside the sterile packaging.The second package got opened and sheath inserted into the body and when the physician went to pull the inner dilator out of the sheath, the lure lock hub broke off".No medical intervention required.No patient harm or injury.The patient's current condition is reported as fine.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET:
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18652236
• Report Number: 1036844-2024-00005
• Device Sequence Number: 8276766
• Product Code: DQY
• UDI-Device Identifier: 00801902001726
• UDI-Public: 00801902001726
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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 Catalogue Number: CL-07065
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male