MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-3/4"; CATHETER PERCUTANEOUS

Catalog Number	RA-04020-SP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was initially reported via medwatch report "an arterial catheter was used to access the left radial artery, and the guide wire of the catheter sheared and a fragment of it was lodged on the left arm soft tissue.Vascular surgery and ir were consulted, and no interventions were recommended.Additional information reports "the plan is for the patient to have a surgical procedure to remove the retained equipment.The retained instrument remains in the patient." the patient's current condition is reports "the patient is living at home independently at this time.From the follow up appointment notes it states the patient has returned to work.".
Event or Problem Description
It was initially reported via medwatch report "an arterial catheter was used to access the left radial artery, and the guide wire of the catheter sheared and a fragment of it was lodged on the left arm soft tissue.Vascular surgery and ir were consulted, and no interventions were recommended.Additional information reports "the plan is for the patient to have a surgical procedure to remove the retained equipment.The retained instrument remains in the patient." the patient's current condition is reports "the patient is living at home independently at this time.From the follow up appointment notes it states the patient has returned to work.".
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided three photos for evaluation.The complaint of guidewire separated in use was able to be confirmed by the photos as they revealed a complete separation of the distal end of the guidewire.However, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel.Precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture." the customer report of guidewire separated in use was confirmed by visual inspection of the customer supplied photos as they revealed a complete separation at the distal end of the guidewire.However, full complaint verification testing to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• 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: 20460114
• Report Number: 9680794-2024-01027
• Device Sequence Number: 15423937
• Product Code: DQY
• UDI-Device Identifier: 00801902027528
• UDI-Public: (01)00801902027528(11)240306(17)290228(10)14F24C0002(21)
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: RA-04020-SP
• Device Lot Number: 14F24C0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2024
• 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