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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 Problems Kinked (1339); Physical Resistance (2578)
Patient Problem Hematoma (1884)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The preliminary evaluation of the returned device indicates arterial - swg/catheter resistance - kinked.Additional patient information: a small hematoma was observed at the insertion site.Post removal of the device the patient had a good radial pulse and blood flow to the hand and fingers and a positive allen test.No other issue reported.
 
Event Description
The customer reports: when attempting to withdraw the needle from the catheter, the needle would not disengage from the catheter.The inserting clinician noted the failure close to the point where the needle was being withdrawn by the hub.After continued failed attempts to withdraw the needle the entire catheter line needed to be removed.The clinician noticed swelling around the site and decided to attempt access on the patients left radial artery.Unfortunately, they were unable to successfully place another a-line.
 
Event Description
The customer reports: when attempting to withdraw the needle from the catheter, the needle would not disengage from the catheter.The inserting clinician noted the failure close to the point where the needle was being withdrawn by the hub.After continued failed attempts to withdraw the needle the entire catheter line needed to be removed.The clinician noticed swelling around the site and decided to attempt access on the patients left radial artery.Unfortunately, they were unable to successfully place another a-line.
 
Manufacturer Narrative
(b)(4).The customer returned a used radial artery catheterization device with the catheter still on the introducer needle for evaluation.Visual inspection of the device revealed a buildup of dried blood in the area of the needle hub.In addition, the spring-wire guide (swg) was kinked near the distal tip.Microscopic examination confirmed the kink in the swg and revealed one side of the catheter tip was folded in and contained a hole.The hole appeared as though it was created due to being pierced by a needle.No other defects were discovered.The kink in the swg was located approximately 12 mm from the distal end of the swg.The hole in the catheter body was located on the distal tip.The outer diameter of the returned guide wire, the inner and outer diameter of the catheter, and the outer diameter of the introducer needle were measured and all were found to be within specification.Once the blood was removed from the needle hub, the guide wire was able to retract back into the catheterization device despite the kink found during visual inspection.A device history record was performed with no relevant findings.The instructions for use provided with this kit warns the end user to not retract the spring-wire guide against edge of needle while in vessel to minimize the risk of spring-wire guide damage.If resistance is encountered during spring-wire guide advancement withdraw entire unit and attempt new puncture.The ifu also warns to not reinsert the needle into catheter to minimize risk of catheter damage.The reported event of catheter, needle, and swg resistance was confirmed by complaint investigation.The customer returned a kinked swg and a catheter that contained a hole near the distal tip.It is likely that the hole was created due to the catheter being pierced by the introducer needle during insertion, causing catheter, needle, and swg resistance while attempting to remove the devices.The swg, needle and catheter all met dimensional requirements, and a device history record was performed with no manufacturing related findings.Based on the sample received , it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
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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 Key7629194
MDR Text Key112145856
Report Number9680794-2018-00146
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
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Catalogue NumberRA-04020
Device Lot Number14F18A0002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Initial Date Manufacturer Received 06/22/2018
Initial Date FDA Received06/22/2018
Supplement Dates Manufacturer Received07/25/2018
Supplement Dates FDA Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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