MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; SALINE VASCULAR ACCESS FLUSH

Catalog Number	ASK-04001-VCUH3
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: when the physician was inserting the peel away sheath into the upper arm of the patient, resistance was encountered.When the sheath was removed it was noted that the tip of the sheath was deformed, and the body had crumpled.Another sheath was used to complete the procedure successfully.The patient was reported as fine post the incident.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The report of a damaged peel-away body was confirmed through complaint investigation of the returned sample.The customer returned one peel-away sheath with dilator assembly for analysis.Signs-of-use in the form of biological material were observed on the sheath body.Visual analysis revealed that the sheath body and the sheath tip were crimped/folded.White stress marks were also observed.No other defects were observed on the sheath nor the dilator.The crimping on the body measured 41mm-57mm via calibrated ruler from the tabs.The sheath body length measured 2 13/16" via calibrated ruler, which was within the specification limits of 2 5/8"-2 7/8" per the sheath with dilator product drawing.The sheath outer diameter measured 0.099" via calibrated caliper, which was within the specification limits of 0.093"-0.099" per the sheath extrusion product drawing.The sheath inner diameter at the proximal end measured 0.076" via calibrated pin gauge, which equals the nominal value of 0.076" per the sheath extrusion product drawing.The dilator outer diameter measured 0.073" via calibrated caliper, which was within the specification limits of 0.073"-0.075" per the dilator extrusion product drawing.Functional inspection was performed per ifu statement, "check peel-away sheath placement by holding sheath in place, twist dilator hub counterclockwise to release dilator hub from sheath hub, withdraw guidewire and dilator sufficiently to allow blood flow".The returned dilator was able to be removed and re-inserted through the sheath with little to no issue.Manufacturing unit confirmed that the damage likely occurred due to force applied by the customer during insertion.The ifu provided with th e kit informs the user, "do not withdraw dilator until sheath is well within vessel to reduce risk of damage to sheath tip".The ifu also states, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding".A device history record review was performed, and no relevant findings were identified.Based on the customer report, the sample received, and the comments from manufacturing, 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 was inserting the peel away sheath into the upper arm of the patient, resistance was encountered.When the sheath was removed it was noted that the tip of the sheath was deformed, and the body had crumpled.Another sheath was used to complete the procedure successfully.The patient was reported as fine post the incident.

• Brand Name: ARROW ACCESS TRAY
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18147012
• Report Number: 9680794-2023-00890
• Device Sequence Number: 6875028
• Product Code: NGT
• UDI-Device Identifier: 10801902214895
• UDI-Public: 10801902214895
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K192414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 03/31/2025
• Device Catalogue Number: ASK-04001-VCUH3
• Device Lot Number: 33F23G0262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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: Female