MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45703-XP1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "spring wire guide kinks easily".No patient har or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr number include: 9680794-2024-00226, 9680794-2024-00310, and 9680794-2024-00225.
Additional Manufacturer Narrative
(b)(4), the report that the guide wire separated was confirmed through examination of the returned sample.The customer returned one guide wire and its advancer for analysis.The guide wire was not returned within the advancer.Signs of use were observed on the guide wire.Visual analysis revealed the guide wire was unravelled and separated towards the proximal end and had multiple kinks throughout the body.The proximal weld of the guide wire was separated from both the core and coil wire and was not returned.The proximal end of the core wire was broken and protruding out of the coil wire.The distal j-bend was misshapen but intact.Microscopic examination revealed that exposed proximal core wire tip was tapered and discoloured at the point of separation.The distal weld appeared to be full and spherical.The guide wire met all dimensional requirements during investigation testing.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso s tandard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.The damage on the guide wire is consistent with unintentional use error (undue force); however, without the complete guide wire returned, the root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "spring wire guide kinks easily".No patient har or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr number include: 9680794-2024-00249, 9680794-2024-00226, 9680794-2024-00310, and 9 680794-2024-00225.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 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: 18893793
• Report Number: 9680794-2024-00227
• Device Sequence Number: 7505301
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: 20801902117216
• 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: Physician
• 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: 01/31/2025
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 33F23H0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• 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: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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