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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-1/2"; WIRE GUIDE CATHETER
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ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-1/2"; WIRE GUIDE CATHETER Back to Search Results
Catalog Number RA-04220
Device Problems Kinked (1339); Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has been received by the manufacturer.However, the investigation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the investigation.
 
Event Description
Customer complaint alleges the inserter experienced difficulty with threading the wire.Upon access, the wire became stuck and could not pass through the needle.It was reported the device was removed entirely.It was reported there was no injury or consequence to the patient.
 
Manufacturer Narrative
(b)(4).Returned was a radial artery catheterization device consisting of a guide wire advancer tube, a guide wire and an introducer needle.The catheter was not returned.The device showed evidence of use.The device was returned with a portion of the guide wire advanced out the distal end of the needle bevel.The swg handle was approximately half way down the advancer tube.The exposed guide wire appeared to bent and kinked.Microscopic examination confirmed that the exposed guide wire had offset coils adjacent to the distal weld and was kinked/offset at the location the guide wire exited the needle bevel.The distal weld was present and appeared full and spherical.The introducer needle and advancer tube appeared typical with no defects or anomalies.The device was returned with 10 mm of the guide wire was advanced out of the needle bevel.Offset coils were located 2 mm from the distal tip and at the location the guide wire exited the needle bevel.The needle and guide wire met all relevant dimensional specifications.The guide wire was able to be fully retracted into the needle, however, dried blood and guide wire damage prevented the guide wire from easily being advanced back and forth through the needle cannula.A manual tug test confirmed the distal weld was intact.A device history record review was performed on the device including the guide wire and needle cannula and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit contains suggested techniques for guide wire insertion to prevent damage.The ifu cautions that if resistance is encountered while advancing spring-wire guide do not force feed.It also warns to not retract spring-wire guide against the edge of the needle while in vessel to minimize the risk of spring-wire guide damage.The report of a kinked guide wire was confirmed through examination of the returned sample.The catheterization device was returned with the guide wire advanced out of the needle bevel.The guide wire had multiple kinks and offset coils in the exposed portion of the body.The needle and guide wire measured within specification for all relevant dimensional requirements.A dhr review was performed and it did not reveal any manufacturing related issues.Based on the nature of the damage to the wire and the information reported, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer complaint alleges the inserter experienced difficulty with threading the wire.Upon access, the wire became stuck and could not pass through the needle.It was reported the device was removed entirely.It was reported there was no injury or consequence to the patient.
 
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Brand Name
ARROW RA CATH SET: 20 GA X 1-1/2"
Type of Device
WIRE GUIDE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
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
9194334854
MDR Report Key6893383
MDR Text Key87618628
Report Number9680794-2017-00209
Device Sequence Number1
Product Code DQX
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/30/2022
Device Catalogue NumberRA-04220
Device Lot Number14F17D0255
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2017
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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