MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45552-VPSB
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "upon insertion of the guidewire the inserter went to slide the glide thru sheath on to the wire when he felt a "notch" on the side of the plastic sheath.At that point he had to open a stand alone sheath to use.".
Event or Problem Description
It was reported that: "upon insertion of the guidewire the inserter went to slide the glide thru sheath on to the wire when he felt a "notch" on the side of the plastic sheath.At that point he had to open a stand alone sheath to use.".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.The complaint of peel-away sheath body damaged was able to be confirmed by the photo.The photo revealed that the sheath body was crimped/deformed on one blue score line.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The 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 body damaged was able to be confirmed by the photo.The photo revealed that the sheath body was crimped/deformed on one blue score line.Based on the customer report and photo, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further evaluate the issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP
• 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: 20083674
• Report Number: 9680794-2024-00810
• Device Sequence Number: 7847751
• Product Code: LJS
• UDI-Device Identifier: 10801902208627
• UDI-Public: (01)10801902208627(11)240509(17)250731(10)33F24C0287(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123759
• 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): 07/31/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: DLX-45552-VPSB
• Device Lot Number: 33F24C0287
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown