MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-42703-XP1A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "spring wire guide kinks easily".No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2024-00226, 9680794-2024-00310, 9680794-2024-00227.
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The customer returned one guide wire for analysis.The guide wire was returned within its advancer tubing and was kinked.Visual inspection of the returned guide wire revealed one kink and one bend in its body.Microscopic examination confirmed the damage.The distal j-bend was misshapen.Both welds were observed to be present and appeared to be full and spherical.The bends in the guide wire measured 25mm and 453mm via calibrated ruler from the distal end.The total length of the guide wire measured 602mm via calibrated ruler, which was within the specifications of 596-604mm per product drawing.The guide wire outer diameter (od) measured 0.79mm via calibrated caliper, which is within the specifications of 0.788-0.826mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the undamaged portions of the guide wire threaded through a lab inventory ars and 18 ga introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds are intact.The instructions-for-use (ifu) provided with the kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested." the returned guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "spring wire guide kinks easily".No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2024-00226, 9680794-2024-00310, 9680794-2024-00227, 9680794-2024-00249.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 18893723
• Report Number: 9680794-2024-00225
• Device Sequence Number: 7514692
• Product Code: FOZ
• UDI-Device Identifier: 10801902117080
• UDI-Public: 10801902117080
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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): 02/19/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: CDC-42703-XP1A
• Device Lot Number: 36F22J0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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