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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS Back to Search Results
Model Number IPN917452
Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem Perforation of Vessels (2135)
Event Date 02/22/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: during a second attempt to insert a central venous line, it was impossible to remove the guide; the ultrasound showed that it went through the jugular vein.Guide was removed after mini-incision: a knot had formed at the end of the guide (at the level of the flexible j-fold).Guide removed after short incision and compression , no hematoma on cervical echo.Another cvc was inserted in contralateral.Additional information: the physician found it impossible to advance the wire on the first puncture, so another puncture was performed.The guide advanced a bit but got stuck again and they were unable to removed it.An ultrasound showed that the wire appeared to puncture the vessel.On the surgeon's advice, as the wire was not touching the carotid artery, they made an incision and forcefully removed the guide.They found the guide to be knotted at the end.The patient was reported as fine post the procedure.
 
Manufacturer Narrative
(b)(4), the actual device was not returned; however, the customer provided one photo for analysis.The complaint of a knotted guide wire was able to be confirmed by the photo.The image shows the distal end of a used guide wire that has formed into a knot.The customer noted that the knotting of the guide wire was likely related to insertion technique issues; however, a complete visual inspection to evaluate the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "if resistance is encountered when attempting to remove guidewire after catheter placement, guidewire may be kinked around tip of catheter within vessel".The customer report of a knotted guide wire was confirmed by visual inspection of the customer supplied photo.The customer provided image shows the distal end of a used guide wire that has formed into a knot.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: during a second attempt to insert a central venous line, it was impossible to remove the guide; the ultrasound showed that it went through the jugular vein.Guide was removed after mini-incision: a knot had formed at the end of the guide (at the level of the flexible j-fold).Guide removed after short incision and compression , no hematoma on cervical echo.Another cvc was inserted in contralateral.Additional information: the physician found it impossible to advance the wire on the first puncture, so another puncture was performed.The guide advanced a bit but got stuck again and they were unable to removed it.An ultrasound showed that the wire appeared to puncture the vessel.On the surgeon's advice, as the wire was not touching the carotid artery, they made an incision and forcefully removed the guide.They found the guide to be knotted at the end.The patient was reported as fine post the procedure.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7FR X 20CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
elaine cully
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18967132
MDR Text Key338438915
Report Number3006425876-2024-00256
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN917452
Device Catalogue NumberEU-15703-N
Device Lot Number71F23E1142
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2023
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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