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

Catalog Number	CDC-45552-TTS
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "right basilic vein easily accessed, guidewire with no noted defects, threaded without difficulty through access needle.After placing peel away sheath, unable to remove guidewire.After manipulation and pulling back of the introducer and removing inner cannula was able to remove guidewire and noted looping remained in the wire".As a result, the catheter was removed and a 2nd catheter was inserted in the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The customer provided one image for analysis.Visual analysis revealed that the distal end of the guide wire was bent.The customer also returned one , nitinol guide wire for analysis.No obvious signs of use were observed.The dilator involved with this complaint was not returned.Visual analysis revealed that the distal end of the guide wire was kinked/bent.Microscopic examination confirmed the bending and revealed that the distal weld was intact.The bending on the guide wire measured 415mm-430mm from the proximal tip.The guide wire total length measured 45.1cm, which is within the specification limits of 43.75mm-46.25cm per the guide wire product drawing.The outer diameter of the guide wire measured 0.0175", which is within the specification limits of 0.0160"-0.0185" per the guide wire product drawing.A manual tug test confirmed that the coiled section of the guide wire was secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The ifu also states , "maintain firm grip on guidewire at all times.Keep sufficient guidewire length exposed for handling purposes.A non-controlled guidewire can lead to wire embolus".The report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the coiled section of the nitinol guide wire severely bent/kinked.Despite the damage, the guide wire met all relevant dimensional requirements.The dilator reported as involved with this event was not returned for evaluation.Based on the customer report and the sample received, the root cause cannot be confirmed without the actual dilator also returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "right basilic vein easily accessed, guidewire with no noted defects, threaded without difficulty through access needle.After placing peel away sheath, unable to remove guidewire.After manipulation and pulling back of the introducer and removing inner cannula was able to remove guidewire and noted looping remained in the wire".As a result, the catheter was removed and a 2nd catheter was inserted in the same insertion site.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: PI PICC KIT: 2L 5.5FR 55CM AGBA TIPTRACK
• 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: 18175733
• Report Number: 9680794-2023-00895
• Device Sequence Number: 20746517
• Product Code: LJS
• UDI-Device Identifier: 30801902125386
• UDI-Public: 30801902125386
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2024
• Device Catalogue Number: CDC-45552-TTS
• Device Lot Number: 33F23G0522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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: N/A.
• Patient Sex: Unknown