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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 1-3/4"; WIRE GUIDE CATHETER
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ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; WIRE GUIDE CATHETER Back to Search Results
Catalog Number RA-04020
Device Problem Unraveled Material (1664)
Patient Problems Hematoma (1884); No Consequences Or Impact To Patient (2199)
Event Date 08/31/2020
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The complaint was reported as: right radial arterial catheter attempted by crna.The wire was checked pre-insertion (advanced and retracted with ease).The skin pierced x1.Arterial flow achieved.The wire advanced, however the inserter then claimed they were unable to pass the catheter over its own guide wire.An attempt was made to retract the wire back into the catheter.Resistance was felt and the inserter was unable to retract the wire.An attempt was then made to remove the entire catheter and wire together.It was reported the catheter came out easily but the wire appeared to have uncoiled.The uncoiled portion remained in the patients wrist while the rest of the wire came out.Initial resistance was encountered removing the uncoiled portion of the wire due to its elasticity.The anesthesiologist attempted to gently remove elastic portion from the wrist and was able to remove.A small hematoma on the right wrist was reported with a pressure dressing placed.A bp cuff was moved to the opposite arm.The wire appears to be removed completely, but a post-op right forearm x-ray has been ordered.The patient's condition was reported as fine.
 
Event Description
The complaint was reported as: right radial arterial catheter attempted by crna.The wire was checked pre-insertion (advanced and retracted with ease).The skin pierced x1.Arterial flow achieved.The wire advanced, however the inserter then claimed they were unable to pass the catheter over its own guide wire.An attempt was made to retract the wire back into the catheter.Resistance was felt and the inserter was unable to retract the wire.An attempt was then made to remove the entire catheter and wire together.It was reported the catheter came out easily but the wire appeared to have uncoiled.The uncoiled portion remained in the patients wrist while the rest of the wire came out.Initial resistance was encountered removing the uncoiled portion of the wire due to its elasticity.The anesthesiologist attempted to gently remove elastic portion from the wrist and was able to remove.A small hematoma on the right wrist was reported with a pressure dressing placed.A bp cuff was moved to the opposite arm.The wire appears to be removed completely, but a post-op right forearm x-ray has been ordered.The patient's condition was reported as fine.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned a catheter, with the guide wire still inside, and lidstock for evaluation.After dislodging the guide wire from the catheter, visual analysis confirmed that the guide wire was actually separated and unraveled near the center of the guide wire body.The guidewire was kinked at the distal end and the j-bend was misshapen.The distal weld appeared spherical and intact.No defects or anomalies were observed on the catheter.The total guide wire length measured 135mm, which is within the specification limits of 135-139mm per the guide wire graphic.The guide wire outer diameter measured.446mm, which is within the specification limits of.432-.457mm per the guide wire graphic.The catheter length measured 2.750 inches, which is within the specification limits of 2.715 - 2.755 inches per the catheter graphic.The catheter outer diameter measured 0.046 inches, which is within the specification limits of 0.044 - 0.047 inches per the catheter extrusion graphic.The catheter inner diameter measured 0.032 inches which is within the specification limits of 0.031 - 0.034 inches per the catheter extrusion graphic.The returned guide wire was unable to enter the returned catheter due to the damage.A lab inventory guide wire with the same outer diameter as the guide wire involved with this complaint was inserted through the returned catheter.Little to no resistance was observed.A manual tug test confirmed the distal weld was secure and fully intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit includes the following warnings and cautions for the user: "precaution: if resistance is encountered while advancing spring-wire guide do not force feed.Warning: do not retract spring-wire guide against edge of needle while in vessel to minimize the risk of spring wire guide damage." the customer complaint is confirmed by investigation of the returned sample.The guide wire was separated and unraveled near the center of the guide wire.The guidewire was kinked at the distal end and the j-bend was misshapen.The sample passed dimensional inspection and a device history record review was performed with no relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error (undue force) likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The complaint was reported as: right radial arterial catheter attempted by crna.The wire was checked pre-insertion (advanced and retracted with ease).The skin pierced x1.Arterial flow achieved.The wire advanced, however the inserter then claimed they were unable to pass the catheter over its own guide wire.An attempt was made to retract the wire back into the catheter.Resistance was felt and the inserter was unable to retract the wire.An attempt was then made to remove the entire catheter and wire together.It was reported the catheter came out easily but the wire appeared to have uncoiled.The uncoiled portion remained in the patients wrist while the rest of the wire came out.Initial resistance was encountered removing the uncoiled portion of the wire due to its elasticity.The anesthesiologist attempted to gently remove elastic portion from the wrist and was able to remove.A small hematoma on the right wrist was reported with a pressure dressing placed.A bp cuff was moved to the opposite arm.The wire appears to be removed completely, but a post-op right forearm x-ray has been ordered.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).Medwatch received - #mw5096456.Corrected data: section b.3.-date of event corrected to (b)(6) 2020.Section e.4.-corrected to "yes".
 
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Brand Name
ARROW RA CATH SET: 20 GA X 1-3/4"
Type of Device
WIRE GUIDE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10556524
MDR Text Key208977708
Report Number9680794-2020-00374
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
PMA/PMN Number
K810675
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRA-04020
Device Lot Number14F20B0006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Date Manufacturer Received10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
Patient Outcome(s) Required Intervention;
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