MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPRING WIRE GUIDE COMPONENT; CATHETER INTRAVASCULAR THERAPE

Catalog Number	AW-14735
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: when the pack was opened the swg was found to be unravelled.The issue was identified prior to use, there was no patient involvement.
Event or Problem Description
It was reported that: when the pack was opened the swg was found to be unravelled.The issue was identified prior to use, there was no patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of an unravelled guide wire was confirmed through examination of the returned sample.The customer provided three images and returned one guide wire and lidstock for analysis.The ars was not returned.Definite signs of use in the form of biomaterial were observed.Visual analysis revealed that the guide wire was unravelled from the distal end and contained one major kink along the body.Microscopic examination confirmed that the core wire was broken at the distal end.Both welds were present and spherical.The kink on the guide wire measured 661mm from the proximal tip of the guide wire.The guide wire total length measured 681mm, which was within the specification limits of 679-687mm per the guide wire product drawing.The kink and the guidewire total length were measured via calibrated ruler.The guide wire outer diameter measured 0.840mm via calibrated micrometer, which was within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.Visual analysis of the ars could not be performed as it was not returned.Functional testing of the guide wire could not be performed due to the damage.Functional analysis of the ars could not be performed as it was not returned.A manual tug test confirmed the proximal weld was intact.The ifu provided with this kit warns the user, "warning: do not apply excessive force in removing guide wire.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained, and further consultation requested." a device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size were designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy might present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage might occur if a force greater than the design specification is applied during removal.Based on these circumstances, the appearance of the damage is consistent with unintentional use error.However, without the ars returned for analysis, the potential root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• 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: 18048687
• Report Number: 9680794-2023-00825
• Device Sequence Number: 7465153
• Product Code: FOZ
• UDI-Device Identifier: 10801902122534
• UDI-Public: 10801902122534
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: AW-14735
• Device Lot Number: 14F19F0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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