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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; SALINE VASCULAR ACCESS FLUSH
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ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number ASK-04001-VCUH3
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2023
Event Type  malfunction  
Event 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.
 
Manufacturer Narrative
(b)(4).
 
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 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.
 
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Brand Name
ARROW ACCESS TRAY
Type of Device
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 Key18147012
MDR Text Key328227693
Report Number9680794-2023-00890
Device Sequence Number1
Product Code NGT
UDI-Device Identifier10801902214895
UDI-Public10801902214895
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Catalogue NumberASK-04001-VCUH3
Device Lot Number33F23G0262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2023
Initial Date FDA Received11/16/2023
Supplement Dates Manufacturer Received12/05/2023
Supplement Dates FDA Received12/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED.; NOT REPORTED.
Patient SexFemale
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