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 Code	Material Deformation (2976)
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 doctor tried to insert the introducer sheath with dilator the dilator did not pass over the guidewire." after receipt of the device and its initial investigation, clarification was sent out to the customer.The customer confirmed they were aware of the crimped peel-away.Additional complaint created.Associated complaints: 9680794-2024-00228.Clinical consequences: no clinical consequences".No injury to the patient.No delay in treatment.
Additional Manufacturer Narrative
(b)(4) the customer returned one, opened picc kit for analysis.Signs-of-use in the form of biological material were observed on the catheter over dilator subassembly.Visual analysis revealed that the sheath tip was crimped.Microscopic examination confirmed the damage.The appearance of the damage is consistent with damage resulting from undue force used during an attempted insertion.It was also noted that the dilator tip was crushed, and the guide wire was kinked.These defects will be addressed in associated complaint.The sheath length measured 4"), which is within the specification limits per the sheath product drawing.The sheath outer diameter measured 0.0965", which is within the specification limits per the sheath extrusion product drawing.The sheath inner diameter at the proximal end measured 0.079", which is within the specification limits per the sheath extrusion product drawing.The dilator was removed from the sheath body with little to no resistance.Likewise, the dilator was able to be reinserted and locked onto the sheath tabs.Performed per ifu statement, "check peel-away sheath placement by holding sheath in place, twisting dilator hub counterclockwise to release dilator hub from sheath hub, withdraw guidewire and dilator sufficiently to allow blood flow".A device history record review was performed.The report of a damaged sheath body was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath tip was crimped.The appearance of the damage is consistent with damage resulting from undue force used during an attempted insertion.Despite the damage, the sheath met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18920363
• Report Number: 9680794-2024-00236
• Device Sequence Number: 7683147
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/18/2024
• 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
• Patient Sex: Unknown