MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 16 GA X 27 1/2IN; CATHETER INTRAVASCULAR THERAPE

Catalog Number	AJ-01671
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the user was unable to insert the swg through the catheter because of resistance.There was no reported patient harm.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the user was unable to insert the swg through the catheter because of resistance.There was no reported patient harm.".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, opened picc kit for analysis.The guide wire and the picc catheter were analyzed as part of this complaint investigation.Definite signs of use were observed.Visual analysis revealed that the guide wire contained one kink towards the proximal end.Microscopic examination confirmed the damage to the guide wire and revealed that the distal and proximal welds were spherical and intact.After failing functional testing, the juncture hub was cross sectioned.It appeared as though the juncture hub didn't maintain the same diameter throughout the body, which likely contributed to the guide wire resistance and kinking.The kink on the guide wire measured 845mm from the proximal end.The guide wire total length measured approximately 100cm, which is within the specification limits of 99.4cm-113cm per the guide wire product drawing.The guide wire outer diameter measured 0.03455", which is within the specification limits of.0340"-.0355" per the guide wire product drawing.The catheter body total length from the juncture hub to the distal tip measured 28 3/4", which is within the specification limits of 27 9/16"-29 9/16" per the catheter product drawing.The catheter body outer diameter measured 0.06710", which is within the specification limits of.0655"-.0705" per the catheter extrusion product drawing.The guide wire was inserted through the catheter body and major resistance was encountered within the juncture hub.The guide wire could not completely pass through due to the resistance at the juncture hub.Performed per ifu statement, "thread catheter over guidewire and advance catheter over guidewire to final indwelling position using image guidance or fluoroscopy".The juncture hub was severed to further analyze the location of the resistance.As a result of severing the juncture hub, the catheter body also inadvertently became damaged.A device history record review was performed, and a relevant finding was identified.A non-conformance was created for eb-01671-003a with lot 34c21k0330 regarding a "swg/catheter resistance - kinked".The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.".The report of a kinked guide wire due to resistance within the catheter was confirmed through complaint investigation.Visual analysis confirmed that the guide wire was kinked.Functional inspection revealed resistance was encountered when the guide wire reached catheter juncture hub which likely resulted in the damage to the guide wire.The guide wire could not pass completely through the catheter.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A nonconformance was created to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC SET: 16 GA X 27 1/2IN
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18947988
• Report Number: 9680794-2024-00325
• Device Sequence Number: 15445278
• Product Code: LJS
• UDI-Device Identifier: 10801902094220
• UDI-Public: 10801902094220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042126
• 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): 03/20/2024

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 Catalogue Number: AJ-01671
• Device Lot Number: 14F23G0112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/12/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown