MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR; CATHETER,INTRAVASCULAR,THERAPE

Model Number IPN920209

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the catheter would not pass through the peel-away sheath.A new kit was opened to complete the procedure.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 2-l picc for analysis.The catheter body appeared intentionally severed below the 49cm mark.The severed portion of the catheter and the peel-away sheath were not returned for analysis.Visual inspection of the catheter did not reveal any obvious defects or anomalies.Visual inspection could not be performed on the severed portion of the catheter body nor the peel-away sheath as they were not returned for analysis.The catheter body length from the juncture hub to the severed end measured 19 3/4" which is not within the specification of 21.5"-22" per coated catheter graphic.This indicates that at least 1 3/4" of the catheter was severed and not returned for analysis.The catheter body outer diameter measured.0720" which is within the specification limits of.0690"-.0740" per the catheter extrusion graphic.The distal portion of the catheter body and the peel-away sheath involved with this complaint could not be measured as they were not returned for analysis.The returned catheter was functionally tested per the instructions for use (ifu) provided with the kit which states "advance soft tip guidewire/catheter tip as a unit through peel-away sheath, while maintaining control of distal end of guidewire." the catheter was inserted through a lab inventory peel-away sheath of the same size involved with this complaint.The catheter body passed through the sheath with no resistance.The returned stylet was also able to pass through the catheter body with minimal resistance.Functional testing with the distal end of the catheter body and the peel-away sheath involved in the event could not be performed as they were not returned for analysis.A lab inventory guide wire with a diameter of.018" was inserted through the distal lumen.The guide wire was able to pass completely through the distal extension line and the catheter body with little to no resistance.A device history record review was performed, and a potentially relevant finding was identified.A non-conformance was initiated for picc/delta assembly batch 13c21e1118 to address the issue of a stylet tight in catheter; however, this failure mode cannot be confirmed with the returned sample based on the incomplete sample returned and the functional testing performed.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested".The report of a catheter tight in sheath was not able to be confirmed through complaint investigation.Visual analysis of the catheter did not reveal any defects or anomalies, however, the distal end of the catheter body had been severed and was not returned by the customer.The returned portion of the catheter was able to advance through a lab inventory 14fr peel-away sheath as expected.Additionally, the catheter met all relevant dimensional requirements.Without the peel-away sheath and distal portion of the catheter body returned for analysis, it cannot be confirmed if resistance was encountered when inserting the catheter through the peel-away sheath.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported the catheter would not pass through the peel-away sheath.A new kit was opened to complete the procedure.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR
• Type of Device: 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: 13624794
• MDR Text Key: 286448013
• Report Number: 9680794-2022-00132
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 10801902192568
• UDI-Public: 10801902192568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN920209
• Device Catalogue Number: ASK-45552-CRMC
• Device Lot Number: 13F21L0426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.
• Patient Sex: Female