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

Model Number	IPN036230
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the catheter does not slide over the swg.Clinical consequences: no clinical consequences.The complaint was originally non-reportable, returned device was reviewed and the complaint was changed to swg / catheter.Resistance - swg separated which is reportable.Mdr aware date was 02jan2024.
Event or Problem Description
It was reported that "the catheter does not slide over the swg.Clinical consequences: no clinical consequences.The complaint was originally non-reportable, returned device was reviewed and the complaint was changed to swg / catheter resistance - swg separated which is reportable.Mdr aware date was 02jan2024.
Additional Manufacturer Narrative
(b)(4).The report of separated guide wire was confirmed through complaint investigation of the returned sample.The customer returned one guide wire for analysis.Signs-of-use in the form of biological material was observed on the sample.The catheter involved with this complaint was not returned.Visual analysis revealed that the guide wire was unravelled from the proximal end.Microscopic examination confirmed the damage.It was noted that the coil wire was separated.The separated portion of the coil wire (includes proximal weld) was not returned for analysis.Further analysis of the finished good reported by the customer revealed that this only contains a guide wire component.No catheter is packaged within this reported finished good.Therefore, it could not be determined if the complaint involves an arrow catheter.The kink on the guide wire measured 329mm via calibrated ruler from the distal weld.The guide wire length from the distal weld to the point of separation on the core wire measured 663mm via calibrated ruler, which was not within the specification limits of 679mm-687mm per the guide wire product drawing.This indicated that between 16mm-24mm of the core wire was separated and not returned for analysis.The guide wire outer diameter measured 0.850mm via calibrated caliper, which was within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.Functional testing was not required for this complaint investigation as the catheter involved with this complaint was not returned for analysis.It is also unknown if the catheter involved was an arrow product.A manual tug test confirmed that the distal weld is secure and intact.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire as this can lead to vessel perforation, bleeding, or component damage".A device history record review was performed based on sales history, and no relevant findings were identified.Additional ly, 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 standard 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.Based on the available information, the root cause could not be determined at this time.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: 18434925
• Report Number: 9680794-2024-00009
• Device Sequence Number: 20606105
• Product Code: FOZ
• UDI-Device Identifier: 10801902122534
• UDI-Public: 10801902122534
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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 Model Number: IPN036230
• Device Catalogue Number: AW-14735
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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