MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45552-CURVC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "clinician noticed the tip of the sheath over the dilator buckle when inserting it over the guidewire.The clinician was able to insert it all the way with no issues but did see it buckle.[the device was placed in the] left upper arm, no scar tissue [noted], skin was not tough.No issues gaining access.[issue was identified] prior to advancing sheath.Clinician did not use a new kit.When she advanced the sheath [she] noticed it buckle at the tip of the sheath.The sheath was removed in its entirety." no patient injury, harm, or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed, and there were three potential findings.Non-conformances were initiated for lot#34c22c0032 in regard to "peel-away sheath body damaged in use".Without the sample returned, it cannot be confirmed if the failure mode of this complaint is the same as/relevant to the non-conformance identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the "clinician noticed the tip of the sheath over the dilator buckle when inserting it over the guidewire.The clinician was able to insert it all the way with no issues but did see it buckle.[the device was placed in the] left upper arm, no scar tissue [noted], skin was not tough.No issues gaining access.[issue was identified] prior to advancing sheath.Clinician did not use a new kit.When she advanced the sheath [she] noticed it buckle at the tip of the sheath.The sheath was removed in its entirety." no patient injury, harm, or consequence reported.Patient condition reported as "fine".

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR 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: 18176157
• Report Number: 9680794-2023-00898
• Device Sequence Number: 12668940
• Product Code: LJS
• UDI-Device Identifier: 10801902208733
• UDI-Public: 10801902208733
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 10/24/2023

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: 06/30/2024
• Device Catalogue Number: DLX-45552-CURVC
• Device Lot Number: 33F23B0505
• 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: 10/24/2023
• 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): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown