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

Catalog Number	DLX-45563-CURVC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "one of the lumens ruptured while being used in ct between the zero mark and the hub." the line was removed and replaced.Additional information recieved states "the patient was bleeding but im not sure what the extent of the damage was".The patient's current condition is reported as "unknown" at this time.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, 3-lumen pressure injectable (pi) picc for analysis.Signs of use in the form of biological material were observed inside the extension lines.Initial analysis revealed that the catheter body was returned severed at the 35cm marking.The severed end was not returned for analysis.It is assumed that the catheter body was intentionally severed by the customer.Visual analysis revealed that the catheter body was ruptured adjacent to the zero-centimeter marking.Microscopic examination confirmed the damage and revealed that the appearance of the rupture is consistent with a pressure related incident.Deformation or slight stretching of the catheter body was also noted directly adjacent to the tear, which, in combination with the catheter hole, is consistent with a pressure related rupture.No other defects or anomalies were observed on any other portion of the catheter.The hole in the catheter body was measured from 9mm-13mm from the juncture hub.The total length of the catheter body measured 37.2cm, which indicates that between 18.65cm-20.56cm of the catheter body was severed and no returned.The catheter outer diameter measured 0.078", which is within the specification limits of 0.078"-0.083" per catheter extrusion product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter extension lines were individually flushed using a lab inventory syringe.The proximal and medial extension lines flushed as intended without leaks or blockages observed.The distal extension line (pi) was flushed, and a leak was observed from only the ruptured hole.Biological material was observed within the distal lumen.An occlusion within the catheter body could contribute to overpressure within the lumen and an increased risk of catheter rupture.A lab inventory guide wire was inserted through the distal lumen.When passing through the distal extension line, biological material was observed exiting the lumen.This biological material in combination with over pressurization likely contributed to the event.Once the biological material was cleared, the guide wire passed through the distal lumen with no resistance.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "the maximum pressure of pressure injector equipment used with the pressure injectable picc may not exceed 300 psi (2068.4 kpa).The maximum pressure injection flow rate ranges from 4 ml/sec to 6 ml/sec.Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection".The pressure injection info card states for a 6fr x 55cm, 3-lumen picc, the max indicated pressure injection flow rate for the pink extension line is 6 ml/sec or 186psi during max flow conditions.The report of a ruptured catheter was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the catheter body was ruptured towards the juncture hub.The appearance of the hole is consistent with damage due to over-pressurization within the catheter.During functional testing, biological material was observed within the distal pink lumen of the catheter body.An occlusion within the catheter body could contribute to overpressure within the lumen and an increased risk of catheter rupture.Based on the customer report and the sample received, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "one of the lumens ruptured while being used in ct between the zero mark and the hub." the line was removed and replaced.Additional information received states "the patient was bleeding but im not sure what the extent of the damage was".The patient's current condition is reported as "unknown" at this time.

• Brand Name: ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM TCG
• 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: 22095378
• Report Number: 9680794-2025-00454
• Device Sequence Number: 6906350
• Product Code: LJS
• UDI-Device Identifier: 10801902208740
• UDI-Public: (01)10801902208740(11)241219(17)260227(10)33F24L0503(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/06/2025

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-CURVC
• Device Lot Number: 33F24L0503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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 Sex: Unknown