MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05042
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "a new 4.0 fr bi-lumen picc catheter was inserted into the brachial vein of the right upper limb.The process was carried out by the head nurse in the intensive care unit and under ultrasound guidance for vascular access.During the passage of the catheter, there was difficulty in advancing the course of the vessel, which at the time was suspected of interference with the implantable catheter, so it was reviewed with a chest x-ray where the catheter was observed coiled at the right subclavian level, so it was decided to remove the catheter completely.Picc insertion was then requested by radiology, since the left limb was not accessible due to signs of infection." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows an x-ray image of a torso and per clinial and medical affairs (cma), the reported coil is confirmed by the customer photo.Cma stated that the observed defect is not due to the product but is a result of a patient anatomy issue.The customer report states, "on the other hand, the patient is associated with the risk factor that he had an implantable chamber catheter on the right side, where the procedure was also intended to be performed, which could have contributed to the non-advancement of the picc catheter, however, coiling was evident which may also be attributed to the material." it cannot be determined if the implantable catheter contributed to the coiling of the picc.A device history record review was performed, and there was one potential finding.It was determined that the finding was not relevant to the reported complaint issue.The instructions-for-use (ifu) provided with this kit warns the user, "minimize catheter manipulation throughout procedure to maintain proper catheter tip position." the customer report of catheter difficult to advance and the catheter coiling was confirmed by visual inspection of the customer supplied photo.The probable cause could not be determined from the available information and without the device returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "a new 4.0 fr bi-lumen picc catheter was inserted into the brachial vein of the right upper limb.The process was carried out by the head nurse in the intensive care unit and under ultrasound guidance for vascular access.During the passage of the catheter, there was difficulty in advancing the course of the vessel, which at the time was suspected of interference with the implantable catheter, so it was reviewed with a chest x-ray where the catheter was observed coiled at the right subclavian level, so it was decided to remove the catheter completely.Picc insertion was then requested by radiology, since the left limb was not accessible due to signs of infection." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 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: 19720455
• Report Number: 9680794-2024-00664
• Device Sequence Number: 8033444
• Product Code: LJS
• UDI-Device Identifier: 00801902095367
• UDI-Public: (01)00801902095367(11)230719(17)270228(10)14F23G0123(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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: PR-05042
• Device Lot Number: 14F23G0123
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: Female