MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AM PICC 2L 5.5FRX55CM 80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-45552-HPHNM
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: when the physician tried to insert the introducer sheath with dilator the dilator not passing over the guidewire clinical consequences: no clinical consequences".No injury to the patient.No delay in treatment.No damage to the wire.Additional information: the device has been returned by the account nearly 2 years later.It is observed to be damaged.The complaint has been reopened and changed to reportable.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, opened picc kit for analysis.The 45cm guide wire assembly and the peel-away/dilator subassembly will be analyzed as part of this complaint investigation.Signs of use in the form of biological material were observed.Visual analysis revealed that the guide wire was kinked on the coiled section of the 45cm guide wire.Analysis of the dilator also revealed that the tip was crushed.Microscopic examination confirmed the damage on both components.Scratch marks were observed on the dilator tip.This is damage consistent with the tip being crushed by the customer during use.It was also noted that the sheath tip was split/frayed.The dilator length measured 5 3/16", which is within the specification limits of 5"-5 1/4" per the dilator product drawing.The dilator inner diameter at the proximal end measured 0.023", which is within the specification limits of 0.022"-0.026" per the dilator extrusion product drawing.The dilator outer diameter measured 0.076", which is within the specification limits of 0.076"-0.078" per the dilator extrusion product drawing.The kink on the guide wire measured 37mm from the distal tip.The guide wire total length measured 45.1cm, which is within the specification limits of 43.75mm-46.25mm per the guide wire product drawing.The guide wire outer diameter (on the coiled section) measured 0.017", which is within the specification limits of 0.016"-0.018" per the guide wire product drawing.The returned guide wire was inserted through the returned dilator.Resistance was encountered at the dilator tip; however, the guide wire was able to pass through all other portions of the dilator body with little to no issue.Performed per ifu statement, "thread peel-away sheath/dilator assembly over guidewire".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".The report of a kinked guide wire due to dilator resistance was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was kinked on the coiled section.Microscopic examination confirmed the kink and revealed that the dilator tip was crushed.This damage appears consistent with the dilator tip being pinched during use, which subsequently contributed to the resistance encountered by the customer.Despite the damage, the sample met all relevant dimensional requirements.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: when the physician tried to insert the introducer sheath with dilator the dilator not passing over the guidewire.Clinical consequences: no clinical consequences".No injury to the patient; no delay in treatment; no damage to the wire.Additional information: the device has been returned by the account nearly 2 years later.It is observed to be damaged.The complaint has been reopened and changed to reportable.

• Brand Name: AM PICC 2L 5.5FRX55CM 80CM HYDRO NIT SWG
• 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: 18757201
• Report Number: 9680794-2024-00228
• Device Sequence Number: 20410442
• Product Code: LJS
• UDI-Device Identifier: 00801902095787
• UDI-Public: 00801902095787
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: 08/31/2023
• Device Catalogue Number: PR-45552-HPHNM
• Device Lot Number: 13F21M0578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male