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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR; INTRODUCER CATHETER
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ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR; INTRODUCER CATHETER Back to Search Results
Catalog Number AJ-09886
Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the user attempted to insert the spring wire guide into the introducer needle, it would not advance.The user opened a new kit, but the same issue occurred.A third kit was used to complete the procedure.No patient harm reported.
 
Manufacturer Narrative
(b)(4).The customer returned one spring wire guide (swg) assembly with the swg inserted into a 20 ga introducer needle and a lidstock for evaluation.Visual inspection of the swg revealed one kink and offset coils in the j-bend.No damage was noted to the 20 ga needle.Microscopic examination confirmed both welds were present and spherical.The kink in the guide wire measured at 367 mm from proximal weld.The total length of the swg measured 455 mm which is within specifications of 449.2-458.8 mm per swg product drawing.The outer diameter of the swg measured 0.612 mm which is within specifications of 0.610-0.635 mm per swg product drawing.The od of the needle measured 0.0358" which is within specifications of 0.0355-0.0360" per cannula graphic.The inner diameter of the needle measured 0.027" which is within specifications of 0.027-0.0285" per cannula graphic.The swg was removed from the 20 ga introducer needle with moderate force and revealed biological material on the swg body.The wire and needle were functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "insert introducer needle with attached arrow raulerson syringe into vein and aspirate.Using the two-piece arrow advancer , advance spring-wire guide through syringe into vein.Hold spring-wire guide in place and remove introducer needle and raulerson syringe." the swg was able to pass through the returned 20 ga introducer needle and a lab inventory ars with minimal resistance.A manual tug test confirmed both the proximal and distal welds were intact.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not cut spring-wire guide to alter length.Do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the report that the guide wire kinked during use was able to be confirmed through examination of the returned sample.One kink and offset coils were found in the returned swg.The returned guide wire and 20 ga introducer needle met all relevant dimensional and functional requirements.A device history record review did not identify any manufacturing related issues.Based on the condition of the sample returned, and that the damage occurred during use, 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 user attempted to insert the spring wire guide into the introducer needle, it would not advance.The user opened a new kit, but the same issue occurred.A third kit was used to complete the procedure.No patient harm reported.
 
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Brand Name
ARROW PSI KIT: 8.5 FR
Type of Device
INTRODUCER CATHETER
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 Key14914175
MDR Text Key303921667
Report Number9680794-2022-00430
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K780532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberAJ-09886
Device Lot Number13F21G0369
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received07/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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