MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45563-CURVB
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during a difficult picc insertions, the picc was observed to have coiled on the tiptracker.When inserter pulled back the picc before readvancing, it is believed that the picc pulled back over the stylet, leaving the stylet extending beyond the catheter tip.When the picc was readvanced into the patient, the ecg showed ventricular placement.Trouble shooting was performed, during which it was realized that the stylet had likely extended beyond the tip of the catheter.The picc and stylet were removed entirely from the patient, the stylet was repositioned within the catheter and the catheter was reinserted into the patient.The case was completed successfully." there was no patient harm or injury.No medical intervention required.The patient's current condition is "unknown" at this time.
Additional Manufacturer Narrative
Qn# (b)(4).One vps rhythm dlx k-01352-001 stylet navigation stylet:.018" x 30-25/32" lg, including (b)(6) connector comm: t-port was returned.A visual examination of the stylet and the connector did not reveal any obvious external defects or anomalies.It was reported "during a difficult picc insertions, the picc was observed to have coiled on the tiptracker.When inserter pulled back the picc before readvancing, it is believed that the picc pulled back over the stylet, leaving the stylet extending beyond the catheter tip.When the picc was readvanced into the patient, the ecg showed ventricular placement.Trouble shooting was performed, during which it was realized that the stylet had likely extended beyond the tip of the catheter.The picc and stylet were removed entirely from the patient; the stylet was positioned within the catheter and the catheter was reinserted into the patient.The case was completed successfully".The above information suggests the stylet location was not securely maintained by the t-port connector.Stylet mrq (b)(4) paragraph 8.2.3 minimum retainer holding force, states the peak force to axially slide the stylet through the retainer shall be greater than or equal to 0.5 n (approximately 59.98 gram) when measured after at least one instance of previous retainer movement.No movement of the stylet through the membrane of the t-port extension was observed when a calibrated 50 gram weight was attached to the stylet and then suspended by only holding the t-port connector.The test results confirmed the stylet location was securely maintained by the t-port connector.The reported issue was not reproduced.No problem was found with the ability of the t-port connector to maintain the location of the stylet.A device history record review performed on the t-port connector did not reveal any manufacturing related issues.No further action will be taken.
Event or Problem Description
It was reported "during a difficult picc insertions, the picc was observed to have coiled on the tiptracker.When inserter pulled back the picc before readvancing, it is believed that the picc pulled back over the stylet, leaving the stylet extending beyond the catheter tip.When the picc was readvanced into the patient, the ecg showed ventricular placement.Trouble shooting was performed, during which it was realized that the stylet had likely extended beyond the tip of the catheter.The picc and stylet were removed entirely from the patient, the stylet was repositioned within the catheter and the catheter was reinserted into the patient.The case was completed successfully." there was no patient harm or injury.No medical intervention required.The patient's current condition is "unknown" at this time.

• Brand Name: ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 21890247
• Report Number: 9680794-2025-00326
• Device Sequence Number: 8174577
• Product Code: LJS
• UDI-Device Identifier: 10801902208719
• UDI-Public: (01)10801902208719(11)250129(17)260227(10)33F24L0502(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 02/27/2026
• Device Catalogue Number: DLX-45563-CURVB
• Device Lot Number: 33F24L0502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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