MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-35541-CURVB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "we used this kit to place a picc line for one of our patients.Everything with placing the picc was great, no issues at all until the removal of the dilator.When going to snap and separate the dilator, the cannula actually detached from the wings and therefore became lodged into the patients vasculature.I did what i could to try to recover it at bedside, but ultimately we did have to transfer the patient over to (b)(6).Under fluoroscopy, ir was able to recover the sheath and it was noted that it looked like a coffee straw.It had not separated as it was supposed to." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "we used this kit to place a picc line for one of our patients.Everything with placing the picc was great, no issues at all until the removal of the dilator.When going to snap and separate the dilator, the cannula actually detached from the wings and therefore became lodged into the patients vasculature.I did what i could to try to recover it at bedside, but ultimately we did have to transfer the patient over to littleton ed.Under fluoroscopy, ir was able to recover the sheath and it was noted that it looked like a coffee straw.It had not separated as it was supposed to." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for evaluation.The complaint of peel-away sheath tabs broke off in use was able to be confirmed by the photos as they revealed that the sheath body had completely separated from the tabs adjacent to the juncture.A small portion of the sheath extrusion was still molded to the tabs.The appearance of the damage in the photos is consistent with a manufacturing defect.A device history record review was performed with relevant findings.For part number eb-01041-002 extrus: 1-l 15ga x 4-1/2" ldpe blank and lots 34c23b0191/34c22m0135, three non-conformances were initiated.The failures were related to the sheath tearing incorrectly and prematurely.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage." the complaint of peel-away sheath tabs broke off in use was able to be confirmed by the photos as they revealed that the sheath body had completely separated from the tabs adjacent to the juncture.Based on the customer photo and report, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further evaluate this issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP
• 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: 20514356
• Report Number: 9680794-2024-01048
• Device Sequence Number: 7081932
• Product Code: LJS
• UDI-Device Identifier: 10801902208757
• UDI-Public: (01)10801902208757(11)230708(17)241130(10)33F23G0145(21)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: DLX-35541-CURVB
• Device Lot Number: 33F23G0145
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2023
• 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: Female