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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW(R) VPS(R) ACCESS KIT; VASCULAR POSITIONING SYSTEM TM
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ARROW INTERNATIONAL LLC ARROW(R) VPS(R) ACCESS KIT; VASCULAR POSITIONING SYSTEM TM Back to Search Results
Catalog Number ASK-04001-UCHS
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/12/2024
Event Type  Injury  
Event Description
It was reported that: introducer broke completely off from the wings when the inserter tried to tear the introducer once the picc was placed.Vascular surgery had to do a cut down at the bedside to retrieve the broken off piece of the introducer.An xray was performed before and after cutdown to ensure the entire piece was removed.The reported defect was detected during use on patient.The patient condition was reported as "fine".An injury occurred but not a death.
 
Manufacturer Narrative
Qn # (b)(4).
 
Manufacturer Narrative
(b)(4).The customer returned one fully intact peel-away sheath tab assembly.No extrusion or other components were returned.Definite signs of use were observed in the form of biological material on the distal portion of the tab assembly.Visual analysis revealed that there was no evidence of the sheath extrusion within the tab assembly mold.Microscopic examination confirmed this and confirmed that the tab assembly was fully intact.The tabs were manually pulled apart to further examine the assembly.The tabs separated smoothly with ease and did not reveal evidence of the sheath extrusion.The inner diameter of the tab assembly measured at 0.081".This result is expected as this is equal to the maximum tolerance of the sheath extrusion outer diameter (0.075"-0.081") per sheath extrusion product drawing.Note: the inner diameter of the tab molds may appear to be widened; this is due to inadvertent widening of the inner mold during dimensional analysis with pin gauges.Functional inspection was performed by manually pulling apart the tab assembly.The tabs were able to smoothly separate from each other with ease.A device history record review was performed, and a potentially relevant finding was identified.For part number eb-01041-002, three non-conformances were identified for the relevant batch (40014701, 40014843 and 40014920).The failure mode identified in these non-conformances is different than the observed failure mode for this complaint.The instructions for use (ifu) provided with this kit warns the user, "advance catheter, with stylet slowly through peel-away sheath to final indwelling position.Retract and/or gently flush while advancing catheter if resistance is met." the customer report of a broken peel away sheath tab was confirmed by visual inspection of the returned sample.The customer returned one fully intact peel-away sheath tab assembly.Visual analysis revealed that there was no evidence of the sheath extrusion within the tab assembly mold.Microscopic examination confirmed this and confirmed that the tab assembly was fully intact.The tabs were manually pulled apart to further examine the assembly.The tabs separated smoothly with ease and did not reveal evidence of the sheath extrusion.The tab assembly met all relevant dimensional and functional requirements.Based on the failure mode observed, manufacturing caused or contributed to the issue.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
 
Event Description
It was reported that: introducer broke completely off from the wings when the inserter tried to tear the introducer once the picc was placed.Vascular surgery had to do a cut down at the bedside to retrieve the broken off piece of the introducer.An xray was performed before and after cutdown to ensure the entire piece was removed.The reported defect was detected during use on patient.The patient condition was reported as "fine".An injury occurred but not a death.
 
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Brand Name
ARROW(R) VPS(R) ACCESS KIT
Type of Device
VASCULAR POSITIONING SYSTEM TM
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 Key18683470
MDR Text Key335072972
Report Number9680794-2024-00161
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103255
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue NumberASK-04001-UCHS
Device Lot Number33F23K0839
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received02/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2023
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 Outcome(s) Required Intervention;
Patient SexMale
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