MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45563-CURVC
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "during the case, the nurse attempted to insert the glidethru sheath over dilator over the guidewire.When the peel-away portion reached the patients skin, she was unable to advance and the peel-away portion began to "turtleneck".Another kit was opened and a new sheath was used with no issues.".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one sheath and dilator for analysis.Definite signs of use in the form of biological material were observed on the returned components.Visual analysis revealed that the sheath tip was damaged and folded, which is consistent with the user report that the sheath tip appeared to "turtleneck".The peel-away sheath and dilator were functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "ensure dilator is in position and locked to hub of sheath." the dilator was removed , reinserted back into the sheath, and locked into the sheath hub.The dilator was able to pass through the sheath tip with little to no resistance.R & d and manufacturing were previously consulted regarding investigations of this nature.They stated that various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user.Due to the possibility that manufacturing contributed to this damage, they will further investigate this issue.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs 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.Precaution: do not withdraw dilator until sheath is well within vessel to reduce risk of damage to sheath tip." the report of peel-away body damage was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath tip was damaged and folded back.Despite the damage, the sheath and met all relevant functional requirements.Various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user, therefore, the root cause is undetermined.A non-conformance was initiated to further investigate potential root causes at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "during the case, the nurse attempted to insert the glidethru sheath over dilator over the guidewire.When the peel-away portion reached the patients skin, she was unable to advance and the peel-away portion began to "turtleneck".Another kit was opened and a new sheath was used with no issues.".

• Brand Name: ARROW AGBA PICC NAVICURVE: 3L 6FR 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: 20333249
• Report Number: 9680794-2024-00958
• Device Sequence Number: 7836191
• Product Code: LJS
• UDI-Device Identifier: 10801902208740
• UDI-Public: (01)10801902208740(11)240523(17)251130(10)33F24A0559(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 11/30/2025
• Device Catalogue Number: DLX-45563-CURVC
• Device Lot Number: 33F24A0559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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: Male