MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-L 16 GA X 27-1/2 IN (70 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PS-01672
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "pcc bilumen catheter is passed to guarantee medical treatment of 44 days in the left upper limb without complication, it is evidenced by x- rays that it has been angled why it is decided to accommodate the control x-ray continues to show the acode it is decided to withdraw evidencing that it comes out elbowed and cannot be removed through the insertion point it is indicated to the doctor who determines evaluation by peripheral vascular cx to remove it." additional information reports there was "damage to the intimal layer of the vein in the catheter path." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "pcc bilumen catheter is passed to guarantee medical treatment of 44 days in the left upper limb without complication, it is evidenced by x- rays that it has been angled why it is decided to accommodate the control x-ray continues to show the acode it is decided to withdraw evidencing that it comes out elbowed and cannot be removed through the insertion point it is indicated to the doctor who determines evaluation by peripheral vascular cx to remove it." additional information reports there was "damage to the intimal layer of the vein in the catheter path." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided three photos for evaluation.The complaint of catheter knotted in patient was able to be confirmed by the third photo as it revealed an obvious knot in the catheter body near the distal tip.A complete visual inspection could not be performed as no sample was returned for analysis.Clinical and medical affairs (cma) was consulted as part of this investigation.Cma stated that this failure mode is an inherent risk based on patient anatomy and insertion technique.Insertion through a tortuous path along with improper catheter insertion can result in the catheter knotting within the vessel.Per cma, it can be detected during proper catheter placement if the catheter is in the appropriate location.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.The instructions for use (ifu) provided with this kit warns the user, "minimize catheter manipulation after procedure to maintain proper catheter tip position.Procedure must be performed by trained personnel well versed in anatomical landmarks, safe technique and potential complications." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC SET: 2-L 16 GA X 27-1/2 IN (70 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 20684633
• Report Number: 9680794-2024-01100
• Device Sequence Number: 7281537
• Product Code: LJS
• UDI-Device Identifier: 00801902095848
• UDI-Public: (01)00801902095848(11)240617(17)250831(10)14F24F0066(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: PS-01672
• Device Lot Number: 14F24F0066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Age: 71 YR
• Patient Sex: Male