MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH KIT: 20 GA X 1-3/4"; CATHETER PERCUTANEOUS

Model Number	IPN037078
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The doctors in ccu were placing a radial arterial line in patient.They did not have any difficulty advancing the wire but when they advanced the catheter they met resistance.They removed both the wire and catheter and found the wire was bent and a piece of the white catheter tip was broken off.An ultrasound and "other tests" performed to determine if the tip had come off within the patient and the tip was not located in the patient.The patient's condition was reported as fine.
Event or Problem Description
The doctors in ccu were placing a radial arterial line in patient.They did not have any difficulty advancing the wire but when they advanced the catheter they met resistance.They removed both the wire and catheter and found the wire was bent and a piece of the white catheter tip was broken off.An ultrasound and "other tests" performed to determine if the tip had come off within the patient and the tip was not located in the patient.The patient's condition was reported as fine.
Additional Manufacturer Narrative
Qn #(b)(4).The customer returned one catheter from a ra catheterization device.Signs-of-use in the form of biological material was observed.Visual analysis revealed that the catheter body was severed.The severed portion was not returned for analysis.Microscopic examination revealed that the point of separation was relatively smooth and uniform, indicating that contact with sharps caused or contributed to this event.Scratch marks were also observed directly adjacent to the separation.The catheter total length measured 53mm, which indicates that at least.628"-.668" of the catheter body was severed and not returned (per measurement in the catheter graphic).The catheter body outer diameter measured.045" , which is within the specification limits of.044"-.047" per the catheter extrusion graphic.The catheter body inner diameter measured.032", which is within the specification limits of.031"-.034" per the catheter extrusion graphic.A lab inventory introducer guide wire with a diameter of.018" was inserted through the catheter.Little to no resistance was observed.Performed per ifu statement, "stabilize position of introducer needle and carefully advance spring-wire guide into vessel using spring-wire guide handle".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "once the catheter is partially threaded off the needle, do not attempt to advance needle into catheter again - this may cause catheter damage.Do not attempt to remove needle protection assembly from needle".The report of a separated arterial catheter was confirmed through complaint investigation.Visual analysis revealed that the catheter body was separated towards the distal tip.Microscopic examination of the point of separation revealed that the damage appears consistent with the catheter body being threaded back over the needle bevel during insertion.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1-3/4"
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11903815
• Report Number: 9680794-2021-00263
• Device Sequence Number: 4420981
• Product Code: DQY
• UDI-Device Identifier: 10801902121551
• UDI-Public: 10801902121551
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: IPN037078
• Device Catalogue Number: AK-04020-SPC
• Device Lot Number: 13F21B0164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1