MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC: 2-L 5FR X 55CM 130CM HNIT WIRE; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number PR-35552-NL

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that the user attempted to insert the spring wire guide (swg) through the catheter by seldinger method, but the catheter could not be inserted.Therefore, a new kit was opened instead.No patient harm reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one opened picc set with a 2-l catheter and nitinol guide wire for analysis.Initial visual inspection of the catheter revealed no obvious defects or anomalies.Visual inspection of the guide wire revealed one small kink near the distal end of the body.Microscopic examination confirmed the kink.The distal weld was present and was observed to be full and spherical.After performing functional inspection (see below), it was observed that the extension line molding in the juncture hub is narrowed and curved.The kink in the guide wire was measured at 26mm from the distal end.The guide wire total length measured 130.3cm which is within the specifications of 128.75cm-131.25cm per guide wire product drawing.The guide wire outer diameter 0.01810" which is within the specifications of 0.0170"-0.0185" per the guide wire product drawing.The catheter body length measured 21 3/4" which is within the specifications of 21 1/2-22" per the catheter product drawing.The catheter body outer diameter measured 0.07121" which is within the specifications of 0.0705"-0.0715" per the catheter extrusion product drawing.The returned components were functionally tested per the instructions for use (ifu) provided with the kit which states "if 130 cm guidewire is used, insert soft tip of the guidewire through peel-away sheath to desired depth.Thread catheter over guidewire and advance catheter over guidewire to final indwelling position." the returned guide wire was threaded through the distal lumen of the catheter.Major resistance encountered at the level of the juncture hub, to the extent that the guide wire was not able to pass through the catheter.Upon further inspection of the catheter juncture hub, it was observed that the molding in juncture hub was narrowed and curved.A manual tug test confirmed the distal weld is secure on the guide wire.A device history record review was performed, and the following potentially relevant findings were identified: for material c-15802-021d, batches 13c19m0740 and 13c20e1944, two non-conformances were opened in regards to an extension line leak during use.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.".The customer report of guide wire/catheter resistance was confirmed through complaint investigation of the returned sample.The guide wire contained one small kink near the distal end.The catheter and guide wire met all relevant dimensional requirements, however, major resistance was encountered during functional testing.It was observed that the molding in the catheter juncture hub was narrowed and curved, causing the resistance.Based on these circumstances, manufacturing likely caused or contributed to this event.A non-conformance was initiated in order to further investigate this issue.

Event Description

It was reported that the user attempted to insert the spring wire guide (swg) through the catheter by seldinger method, but the catheter could not be inserted.Therefore, a new kit was opened instead.No patient harm reported.

• Brand Name: ARROW PI PICC: 2-L 5FR X 55CM 130CM HNIT WIRE
• 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: 14604361
• MDR Text Key: 295492580
• Report Number: 9680794-2022-00391
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: PR-35552-NL
• Device Lot Number: 13F21E0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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