MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SAC KIT: 20 GA X 12CM; CATHETER PERCUTANEOUS

Catalog Number	SAC-01220-X1A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "guidewire shredded.X-ray confirmed that no pieces remained in the patient.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "guidewire shredded.X-ray confirmed that no pieces remained in the patient.
Additional Manufacturer Narrative
Qn# (b)(4).Medwatch voluntary report# mw5158052.The customer returned one guide wire from an arterial kit.No obvious signs of use were observed.Visual analysis revealed that the guide wire was unraveled from one of the ends.Microscopic examination confirmed the unraveling and revealed that the weld (same end as unraveling) was separated from both the core and coil wires.The separated weld was not returned for analysis.Further analysis of the opposite end of the unraveling revealed kinking; however, the weld appeared spherical and intact.Further dimensional analysis revealed that a section of the core wire was also severed and not returned for analysis.The major kinks in the guide wire body were measured 20mm and 40mm from the intact weld.The broken core wire from the intact weld to the point of separation on the core wire measured 306mm, which is not within the specification of 345mm-355mm per the guide wire product drawing.This indicates that between 39mm-49mm of the core wire was severed and not returned for analysis.The guide wire outer diameter measured 0.51mm, which is within the specification limits of 0.508mm-0.533mm per the guide wire product drawing.A manual tug test confirmed that the weld present on the guide wire was secure and intact to both the core and coil wires.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit, "to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel".The ifu also states, "use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire".The report of a separated guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed that a section of the core wire (including the weld) was separated and not returned for analysis.Therefore, dimensional analysis could not verify that the guide wire length was within specification.A device history record review was performed, and no relevant findings were identified.Based on the appearance of the damage, the separation seems consistent with undue force applied by the customer during use; however, this cannot be confirmed without the separated portion also returned to verify it is within dimensional specifications.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW SAC KIT: 20 GA X 12CM
• 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: 20094024
• Report Number: 9680794-2024-00821
• Device Sequence Number: 7784872
• Product Code: DQY
• UDI-Device Identifier: 10801902140989
• UDI-Public: (01)10801902140989(11)240207(17)250831(10)33F24A0995(21)
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: SAC-01220-X1A
• Device Lot Number: 33F24A0995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White