MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 5.5 FR X 8 CM; CATHETER PERCUTANEOUS

Catalog Number	AK-15553
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "wire showed visible defect in the proximal/initial bend of the j-tip." the issue was identified prior to use.Associated complaints: 9680794-2024-00867, 9680794-2024-00961, 9680794-2024-00962 and 9680794-2024-00963.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The complaint of a kinked guide wire was able to be confirmed by the photos.The customer also returned one, unopened ak-15553 kit including one guide wire within its advancer for analysis.Visual analysis revealed the contents within the kit were mispositioned upon opening.The guide wire was kinked at the distal j-bend where the guide wire exits the straightening tube.The distal j-bend was slightly misshapen but intact.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.The kink in the guide wire was located 11 mm from the distal tip.The overall length of the guide wire measured 450 mm , which is within the specification limits of 449.2-458.8 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.439 mm, which is within the specification limits of 0.432-0.457 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned 21ga introducer needle to functionally test the guide wire.The undamaged portions of the guide wire passed through with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit informs the user , "do not use if package is damaged." the report of a guide wire kinked in package was confirmed through complaint investigation of the returned sample.The customer returned an unopened representative ak-15553 kit, and the kit contents were mispositioned upon opening.Visual analysis revealed the guide wire was kinked on the distal j-bend where the guide wire exits the straightener tube.Despite the damage, the returned guide wire met all relevant dimensional/functional requirements.A device history record review did not identify any manufacturing related issues.Based on the customer report and the sample received, storage and shipping likely caused or contributed to the reported event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 3-LUMEN 5.5 FR X 8 CM
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20265287
• Report Number: 9680794-2024-00960
• Device Sequence Number: 8298733
• Product Code: DQY
• UDI-Device Identifier: 10801902122107
• UDI-Public: (01)10801902122107(11)240624(17)260731(10)33F24E0714(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2024

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: 07/31/2026
• Device Catalogue Number: AK-15553
• Device Lot Number: 33F24E0714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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
• Patient Sex: Unknown