Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CDC-42703-XP1A
Device Problems Unraveled Material (1664); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
Event Type  malfunction  
Event Description
It was reported "spring wire guide kinks easily".No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2024-00226, 9680794-2024-00227, and 9680794-2024-00225.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "spring wire guide kinks easily".No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2024-00226, 9680794-2024-00227,9680794-2024-00249, and 9680794-2024-00225.
 
Manufacturer Narrative
Qn#(b)(4).The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The customer returned one guide wire for analysis.Signs-of-use were observed.Visual inspection of the returned guide wire revealed several kinks in its body.Microscopic examination confirmed the damage.The distal j-bend was misshapen.Both welds were observed to be present and appeared to be full and spherical.The kinks in the guide wire were located 50mm via calibrated ruler and between 315-390mm from the distal end.The total length of the guide wire measured 604mm via calibrated ruler, which was within the specifications of 596-604mm per product drawing.The guide wire outer diameter (od) measured 0.79mm via calibrated caliper, which was within the specifications of 0.788-0.826mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the undamaged portions of the guide wire threaded through a lab inventory ars and 18 ga introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds were intact.The instructions-for-use (ifu) provided with the kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested." the returned guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
Type of Device
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
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18893813
MDR Text Key337744451
Report Number9680794-2024-00310
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10801902117080
UDI-Public10801902117080
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCDC-42703-XP1A
Device Lot Number33F23G0436
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2023
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
NONE REPORTED; NONE REPORTED
-
-