MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH KIT: 20 GA X 1-3/4" (4.45 CM); WIRE, GUIDE, CATHETER

Model Number	IPN036993
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Clinician noticed integral guide wire was distorted upon removing needle/wire from the catheter after placement.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer did not return a complaint sample; however, they supplied a photo showing an arterial catheterization device with the guide wire unraveled.The guide wire appears to be unraveled from the distal tip.The hub of the needle assembled as part of the arterial catheterization device contained obvious signs of use in the form of biological material.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with this kit states the following: "warning: to reduce the risk of spring-wire guide damage, do not retract spring-wire guide against edge of needle while in vessel." "caution: if resistance is encountered during spring-wire guide advancement do not force feed, withdraw entire unit and attempt new puncture." the report that the guide wire unraveled was confirmed through examination of the customer supplied photo.The image showed an arterial catheterization device with the guide wire unraveled.The guide wire appears to be unraveled from the distal tip; however, the actual complaint sample was not returned for evaluation.The device history records for the guide wire were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the guide wire damage could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Clinician noticed integral guide wire was distorted upon removing needle/wire from the catheter after placement.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1-3/4" (4.45 CM)
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12228081
• Report Number: 9680794-2021-00363
• Device Sequence Number: 16474731
• Product Code: DQX
• UDI-Device Identifier: 10801902117813
• UDI-Public: 10801902117813
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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): 07/12/2021

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: 09/30/2022
• Device Model Number: IPN036993
• Device Catalogue Number: ASK-04020-SPH
• Device Lot Number: 13F21B0034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1