ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM
Report
- Report Number
- 9680794-2026-00010
- Event Type
- Injury
- Date Received
- January 27, 2026
- Date of Event
- December 30, 2025
- Report Date
- December 31, 2025
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQX
- PMA / PMN Number
- K810675
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4).
QN# (B)(4). THE CUSTOMER PROVIDED TWO PHOTOS FOR ANALYSIS. THE PHOTOS SHOW AN X-RAY IMAGE OF THE ARTERIAL CATHETER/NEEDLE ASSEMBLY WITHIN THE PATIENT. THE GUIDE WIRE APPEARS TO BE ADVANCED PAST THE DISTAL TIP OF THE NEEDLE AND IS CURLED. THE CUSTOMER ALSO RETURNED A GUIDE WIRE FOR ANALYSIS. THE INTRODUCER NEEDLE WAS NOT RETURNED. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED. VISUAL ANALYSIS REVEALED THE GUIDE WIRE WAS BROKEN AND SEPARATED TOWARDS THE DISTAL END. ONE KINK WAS TOWARDS THE PROXIMAL END, AND ANOTHER WAS TOWARDS THE DISTAL END. THE DISTAL WELD WAS PRESENT NEITHER AT THE END OF THE CORE WIRE NOR THE COIL WIRE. THE DISTAL END OF THE CORE WIRE TIP WAS TAPERED AT THE POINT OF SEPARATION. THE PROXIMAL WELD WAS PRESENT AND APPEARED FULL AND SPHERICAL. VISUAL INSPECTION OF THE INTRODUCER NEEDLE COULD NOT BE PERFORMED AS THE INTRODUCER NEEDLE WAS NOT RETURNED. THE KINKS IN THE GUIDE WIRE MEASURED 52 MM AND 343 MM FROM THE PROXIMAL TIP. THE BROKEN CORE WIRE MEASURED 429 MM, WHICH IS NOT WITHIN THE SPECIFICATION LIMITS OF 449.2-458.8 MM PER GUIDE WIRE PRODUCT DRAWING; THEREFORE, AT LEAST 20.2 MM OF THE CORE WIRE APPEARS TO BE MISSING. THE GUIDE WIRE OUTER DIAMETER MEASURED 0.611 MM , WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.610-0.635 MM PER GUIDE WIRE PRODUCT DRAWING. A MANUAL TUG TEST CONFIRMED THAT THE PROXIMAL WELD WAS SECURE AND INTACT. CLINICAL AND MEDICAL AFFAIRS (CMA) WAS CONSULTED, AND THEY STATED THAT THE X-RAY IMAGE DEMONSTRATES THE WIRE SHEARING DUE TO INTERACTION BETWEEN THE NEEDLE AND WIRE WHILE THE CLINICIAN WAS USING OR CHANGING THE NEEDLE ANGLE DURING WIRE INSERTION OR REMOVAL. THE WIRE APPEARS TO BE CUT BY THE NEEDLE CAUSING IT TO SHEAR AND UNRAVEL AS THE WIRE IS BEING REMOVED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER , "WARNING: TO REDUCE THE RISK OF GUIDEWIRE DAMAGE, DO NOT RETRACT GUIDEWIRE AGAINST EDGE OF NEEDLE WHILE IN VESSEL. PRECAUTION: USE CARE WHEN REMOVING GUIDEWIRE. IF RESISTANCE IS ENCOUNTERED, REMOVE GUIDEWIRE AND CATHETER TOGETHER AS A UNIT. USE OF EXCESSIVE FORCE MAY DAMAGE CATHETER OR GUIDEWIRE." THE CUSTOMER REPORT OF THE GUIDE WIRE SEPARATING WITHIN THE PATIENT WAS CONFIRMED BY INVESTIGATION OF THE CUSTOMER SUPPLIED PHOTOS AND THE SAMPLE RECEIVED. A PORTION OF THE GUIDE WIRE WAS MISSING, AND THE INTRODUCER NEEDLE WAS NOT RETURNED. THE GUIDE WIRE HAD TWO KINKS AND WAS BROKEN AND SEPARATED TOWARDS THE DISTAL END. THE DISTAL WELD WAS NEITHER PRESENT AT THE END OF THE CORE WIRE NOR COIL WIRE. THE PHOTOS SHOW AN X-RAY IMAGE OF THE GUIDE WIRE SEPARATING WITHIN THE PATIENT. CLINICAL MEDICAL AFFAIRS WAS CONSULTED, AND THEY STATED THAT THE X-RAY IMAGE DEMONSTRATES THE WIRE SHEARING DUE TO INTERACTION BETWEEN THE NEEDLE AND WIRE WHILE THE CLINICIAN WAS USING OR CHANGING THE NEEDLE ANGLE DURING WIRE INSERTION OR REMOVAL. THE WIRE APPEARS TO BE CUT BY THE NEEDLE CAUSING IT TO SHEAR AND UNRAVEL AS THE WIRE IS BEING REMOVED. ADDITIONALLY, THE IFU PROVIDED WITH THIS KIT WARNS THE USER, "WARNING: TO REDUCE THE RISK OF GUIDEWIRE DAMAGE, DO NOT RETRACT GUIDEWIRE AGAINST EDGE OF NEEDLE WHILE IN VESSEL. PRECAUTION: USE CARE WHEN REMOVING GUIDEWIRE. IF RESISTANCE IS ENCOUNTERED, REMOVE GUIDEWIRE AND CATHETER TOGETHER AS A UNIT. USE OF EXCESSIVE FORCE MAY DAMAGE CATHETER OR GUIDEWIRE." A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. ARROW GUIDE WIRES OF THIS DIAMETER ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.0 OR 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE BS EN ISO 110 70:2014 STANDARD OF 1.1 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE DAMAGE. GUIDE WIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT; HOWEVER, THE PROBABLE CAUSE CANNOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE REMAINDER OF THE GUIDE WIRE AND INTRODUCER NEEDLE RETURNED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
IT WAS REPORTED THAT "A FEMORAL ARTERIAL A LINE WIRE CAME APART RIGHT AS I WAS PUTTING THE WIRE IN THE VESSEL, IT GOT STUCK IN THE NEEDLE AND THEN COMPLETELY UNRAVELED, I PULLED THE NEEDLE AND WIRE OUT AS ONE BUT THE TIP OF THE WIRE DID NOT COME OUT. THESE WIRES HAVE BEEN GIVING OTHERS PROBLEMS. AS OF YESTERDAY THE PIECE IS REMAINED IN PATIENT. AND PATIENT WILL NEED SURGICAL REMOVAL. PLANNING UNDERWAY. PER MD ". ADDITIONAL INFORMATION RECEIVED STATES "THE PATIENT HAS A SMALL PIECE OF THE RETAINED WIRE WITHIN HIS THIGH, IT WAS DETERMINED TO BE OF TOO HIGH RISK VS BENEFIT OF REMOVAL, ONLY RECEIVED ADDITIONAL IMAGING FOR THIS TO BE DETERMINED BY VASCULAR SURGERY. PATIENT WAS DISCHARGED HOME IN GOOD CONDITION."
IT WAS REPORTED THAT "A FEMORAL ARTERIAL A LINE WIRE CAME APART RIGHT AS I WAS PUTTING THE WIRE IN THE VESSEL, IT GOT STUCK IN THE NEEDLE AND THEN COMPLETELY UNRAVELED, I PULLED THE NEEDLE AND WIRE OUT AS ONE BUT THE TIP OF THE WIRE DID NOT COME OUT. THESE WIRES HAVE BEEN GIVING OTHERS PROBLEMS. AS OF YESTERDAY THE PIECE IS REMAINED IN PATIENT. AND PATIENT WILL NEED SURGICAL REMOVAL. PLANNING UNDERWAY. PER MD ". ADDITIONAL INFORMATION RECEIVED STATES "THE PATIENT HAS A SMALL PIECE OF THE RETAINED WIRE WITHIN HIS THIGH, IT WAS DETERMINED TO BE OF TOO HIGH RISK VS BENEFIT OF REMOVAL, ONLY RECEIVED ADDITIONAL IMAGING FOR THIS TO BE DETERMINED BY VASCULAR SURGERY. PATIENT WAS DISCHARGED HOME IN GOOD CONDITION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248927 | ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM | WIRE, GUIDE, CATHETER | DQX | ARROW INTERNATIONAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED| NOT REPORTED |