MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS; CATHETER INTRAVASCULAR THERAPE

Catalog Number	ASK-45552-UOI
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "we ran across a situation today where a picc had a pretty bad extravasation due to a hole in the picc." additional information received states "it sounds like the 'hole' was actually found/developed this morning while giving contrast down in ct.They could see the contrast building up in the arm so terminated procedure.Up until that event this morning, picc was functioning normally." the line was removed.The patient had swelling in their arm; however, the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one image for analysis.The image shows the catheter body taped to a board and a patient with a bandage securing biological material.The customer complaint of a hole in the picc could not be confirmed by the image alone.The customer also returned one, 2- lumen pressure injectable picc for analysis.Signs of use in the form of biological material were observed within the extension lines.Visual analysis revealed that the catheter body was ruptured towards the juncture hub.Microscopic examination confirmed the damage and revealed that the appearance of the rupture is consistent with a pressure related break.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 the appearance of over pressuring within the catheter.No damage or anomalies were observed with either of the extension lines.The hole in the catheter body was measured from 30mm to 35mm from the juncture hub.The total length of the catheter body measured 36.60mm, which is not within the specification limits of 55.86cm - 57.77cm per catheter product drawing.This suggests that the customer intentionally trimmed the picc around 19.26cm from the distal end.The catheter outer diameter measured 0.0735", which is within the specification limits of 0.069" - 0.074" 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 extension line flushed as intended without leaks or blockages observed.The distal extension line was flushed, and a leak was observed from only the ruptured hole.Biological material was observed within the distal pink lumen of the catheter body which had formed an occlusion.An occlusion within the catheter body could contribute to overpressure within the lumen and an increased risk of catheter rupture.A lab inventory pin gage was inserted through the lumens of the returned catheter.When passing through the distal extension line, dried 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 long pin gage could pass 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 5.5fr x 55cm, 2-lumen picc, the max indicated pressure injection flow rate for the white and pink extension lines is 5 ml/sec or 208 psi 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 , an occlusion of 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 (occlusion leading to over-pressurization) 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 "we ran across a situation today where a picc had a pretty bad extravasation due to a hole in the picc." additional information received states "it sounds like the 'hole' was actually found/developed this morning while giving contrast down in ct.They could see the contrast building up in the arm so terminated procedure.Up until that event this morning, picc was functioning normally." the line was removed.The patient had swelling in there arm; however, the patient's current condition is reported as "fine".

• Brand Name: ARROW PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS
• 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: 21925153
• Report Number: 9680794-2025-00350
• Device Sequence Number: 8623585
• Product Code: LJS
• UDI-Device Identifier: 10801902215151
• UDI-Public: (01)10801902215151(11)240812(17)250917(10)33F24D0906(21)
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• 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): 04/03/2025

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: 09/17/2025
• Device Catalogue Number: ASK-45552-UOI
• Device Lot Number: 33F24D0906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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