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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 22 GA X 1-3/8"; WIRE GUIDE CATHETER
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ARROW INTERNATIONAL LLC ARROW RA CATH SET: 22 GA X 1-3/8"; WIRE GUIDE CATHETER Back to Search Results
Catalog Number RA-04122
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2024
Event Type  malfunction  
Event Description
It was reported that: "there was no scar tissue.The wire treaded easily, however when the catheter was advanced, resistance was met.I tried to retract the wire but was unable to do this.I then stopped advancing and pulled out the entire line, catheter, and wire.There was more resistance on retraction than expected as well.That is when we noticed the wire kinked and the damaged catheter.No fragments were left in the patient.A new catheter was placed." a photo shows that the guidewire is kinked, and the arterial catheter tip was damaged.Associated complaints 9680794-2024-00216.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4) the customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photo.The images show a kinked guidewire partially advanced through the catheter, however, full complaint verification testing could not be performed as no sample was returned for analysis.The instructions-for-use (ifu) provided with this 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." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported that: "there was no scar tissue.The wire treaded easily, however when the catheter was advanced, resistance was met.I tried to retract the wire but was unable to do this.I then stopped advancing and pulled out the entire line, catheter, and wire.There was more resistance on retraction than expected as well.That is when we noticed the wire kinked and the damaged catheter.No fragments were left in the patient.A new catheter was placed." a photo shows that the guidewire is kinked, and the arterial catheter tip was damaged.Associated complaints 9680794-2024-00215 and 9680794-2024-00216.
 
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Brand Name
ARROW RA CATH SET: 22 GA X 1-3/8"
Type of Device
WIRE GUIDE 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
elaine cully
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18892604
MDR Text Key337527232
Report Number9680794-2024-00215
Device Sequence Number1
Product Code DQX
UDI-Device Identifier00801902002754
UDI-Public00801902002754
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K810675
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
Report Date 02/16/2024
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 Operator Health Professional
Device Catalogue NumberRA-04122
Device Lot Number14F23B0032
Was Device Available for Evaluation? No
Date Manufacturer Received02/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2023
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
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