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

Catalog Number	CL-07824
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "during an ep procedure the dilator snapped off at the hub when the doctor tried to remove it from the sheath.Patient needed to go ir for retrieval.Unfortunately, during the process, it broke again an a piece is now in the patient's lung." the patient's current condition is reported as "unknown".Additional information was requested from the customer; however, further details have not been provided at this time.
Additional Manufacturer Narrative
Qn #: (b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided photos for evaluation.A visual exam was performed and no hub was observed on the proximal end of the dilator.The dilator shaft was observed to be intact.The length is unknown.No picture of the hub was provided.A device history record review was performed on a potential lot number provided by the customer, and no relevant findings were identified.Based on review of the photos, the complaint was confirmed.A capa was previously opened for this issue.The capa identified that the hub separation failure stems from the milling process in manufacturing.The potential lot number provided by the customer is packed with an 8f dilator which is within the scope of the capa.Without a product return, the extent of damage is unknown as the dilator broke twice.First time with the hub and the second time during retrieval of the separated shaft.Therefore, dimensionally, the amount of material missing cannot be confirmed.The extent and use of the dilator in the procedure is unknown.The pictures provided are not clear enough to make a determination if the issue is related to manufacturing.Based on the information, the most likely root cause of the issue is undeterminable.
Event or Problem Description
It was reported "during an ep procedure the dilator snapped off at the hub when the doctor tried to remove it from the sheath.Patient needed to go ir for retrieval.Unfortunately during the process it broke again an a piece is now in the patients lung." the patient's current condition is reported as "unknown".Additional information was requested from the customer; however, further details have not been provided at this time.

• 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: 21995268
• Report Number: 9680794-2025-00411
• Device Sequence Number: 19911308
• Product Code: DQY
• UDI-Device Identifier: 00801902001986
• UDI-Public: (01)00801902001986(11)220413(17)270331(10)14F22C0293(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CL-07824
• Device Lot Number: 14F22C093
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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