MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45541-CURVC
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "spoke with the inserter who told me that during trouble needling, that the guidewire unraveled while she pulled it back through the needle.Pt was taken to interventional radiology to ensure safe removal of the entire wire." no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided four photos for analysis.The complaint of guidewire unraveled was able to be confirmed by the photos.The photos revealed clear visual evidence of unraveling as the guidewire exited the needle cannula.A complete visual inspection could not be performed as no sample was returned for analysis.A review of the customer report revealed the following statement, "the guidewire unraveled while she pulled it back through the needle.".The ifu provided with this kit instructs the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.".Therefore, based on the customer report and customer photos of the sample, intentional use error caused or contributed to this event as the customer did not follow the ifu.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." a review of the customer report revealed the following statement: "the guidewire unraveled while she pulled it back through the needle." which contradicts the statement from the ifu.The complaint of guidewire unraveled was able to be confirmed by the customer photos.The photos revealed clear visual evidence of unraveling as the guidewire exited the needle cannula.A device history record review was performed based on a potential lot from sales history and no relevant findings were identified.A review of the customer report revealed the following statement: "the guidewire unraveled while she pulled it back through the needle.".The ifu provided with this kit instructs the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.".Therefore, based on the customer report and customer photos of the sample, intentional use error caused or contributed to this event as the customer did not follow the ifu.Based on the information provided, the sales representative provided training that reiterated proper guidewire removal technique, therefore no in-service will be initiated at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "spoke with the inserter who told me that during trouble needling, that the guidewire unraveled while she pulled it back through the needle.Pt was taken to interventional radiology to ensure safe removal of the entire wire." no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW AGBA PICC NAVICURVE: 1L 4.5FR 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: 19248666
• Report Number: 9680794-2024-00390
• Device Sequence Number: 17774583
• Product Code: LJS
• UDI-Device Identifier: 10801902208726
• UDI-Public: 10801902208726
• Combination Product (Y/N): N
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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 Catalogue Number: DLX-45541-CURVC
• Device Lot Number: 33F24A0501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown