MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL LINE KIT; CATHETER, PERCUTANEOUS

Catalog Number	ASK-04510-UPM
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the introducer needle goes into the artery and then they put the guidewire through the needle.When she goes to pull the wire out, the tip got stuck on the needle.The wire was able to be removed in full from the patient.It was unraveled." the patient is reported as fine.Associated complaint (b)(4).
Event or Problem Description
It was reported that: "the introducer needle goes into the artery and then they put the guidewire through the needle.When she goes to pull the wire out, the tip got stuck on the needle.The wire was able to be removed in full from the patient.It was unraveled." the patient is reported as fine.Associated complaint (b)(4).
Additional Manufacturer Narrative
(b)(4).Udi number unavailable as complainant did not report a lot number.The actual device was not returned; however, the customer provided a photo for evaluation.The complaint of an unraveled guide wire was confirmed by the photo.The photo shows an unraveled guide wire caught inside an introducer needle.The guidewire appears to be kinked on the needle bevel.A complete visual inspection could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: to reduce the risk of spring-wire guide damage, do not retract spring-wire guide against edge of needle while in vessel." the customer report of an unraveled guide wire was confirmed by visual inspection of the customer supplied photo.The image shows an unraveled guidewire partially advanced through a needle, however, full complaint verification testing could not be performed as no sample was returned for analysis.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: ARTERIAL LINE KIT
• 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: 19357885
• Report Number: 9680794-2024-00470
• Device Sequence Number: 6500127
• Product Code: DQY
• UDI-Device Identifier: 10801902118087
• UDI-Public: 10801902118087
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K810962
• 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): 04/25/2024

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: ASK-04510-UPM
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/17/2024
• 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