MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Model Number	IPN037301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: "the handles of the glide thru sheath broke off when trying to crack the sheath which left the sheath in the tissue which they had to fish out.They got it all out and the patient is fine".It was reported the vascular access nurse who was placing the line was able to pull the pieces of the sheath out of the patient's tissue with "tools she had".No patient injury or consequence was reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "the handles of the glide thru sheath broke off when trying to crack the sheath which left the sheath in the tissue which they had to fish out.They got it all out and the patient is fine".It was reported the vascular access nurse who was placing the line was able to pull the pieces of the sheath out of the patient's tissue with "tools she had".No patient injury or consequence was reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one peel away sheath for analysis.Definite signs of use were observed on the peel away sheath body.Visual analysis of the sheath revealed that both tabs were separated from the sheath body.A portion of the proximal end of the peel-away extrusion was still molded to the tabs.Microscopic examination confirmed the damage and revealed that the point of separation was stretched and jagged.It was also noted that the peel-away sheath was split down the score lines towards the distal portion of the sheath.Functional inspection could not be performed due to the damage.Manufacturing was contacted as a part of this complaint investigation.Based on their feedback, the molding of the sheath to the hub appears aligned as intended.They stated that variation in wall thickness of the white and blue portions during the extrusion process could result in tearing of the sheath, however rare.This failure mode cannot be confirmed since the sheath is destroyed in use.They stated that, based on the appearance of the tearing/damage in this sample, it is more likely that unintentional undue force by the user caused or contributed to the damage.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user "withdraw peel-away sheath over catheter until sheath hub and connected portion of sheath is free from venipuncture site.Grasp tabs of peel-away sheath and pull away from the catheter, while withdrawing from vessel until sheath splits down its entire length." the report that a peel-away tabs separated during use was confirmed through complaint investigation.Visual analysis revealed that both peel-away tabs had separated from the assembly.A portion of the sheath extrusion was still molded to this separated tab.Manufacturing was contacted regarding this failure mode, and they stated that the appearance is consistent with inadvertent damage caused to the sheath during use.Based on the customer report, the sample received, and the comments from manufacturing, it was determined that unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVSCULAR THERAPEU
• 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: 16499220
• Report Number: 9680794-2023-00121
• Device Sequence Number: 12396071
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• 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): 02/07/2023

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: 11/30/2023
• Device Model Number: IPN037301
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 13F22K0450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown