MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATHETERIZATION KIT: 18 GA X 6"; WIRE, GUIDE, CATHETER

Model Number	IPN036984
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the guidewire bent and frayed.The inserter opened another kit and the same thing happened.Two kits used on same patient.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: the guidewire bent and frayed.The inserter opened another kit and the same thing happened.Two kits used on same patient.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of an unraveled spring wire guide was able to be confirmed by the photo.A portion of the core wire was protruding through the coil wire.A complete visual inspection 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 instructions for use (ifu) provided with this kit warns the user, "use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter together as a unit.Use of excessive force may damage catheter or spring-wire guide.To reduce the risk of spring-wire guide damage, do not retract spring-wire guide against edge of needle while in vessel." the customer report of an unraveled spring wire guide was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.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.

• Brand Name: ARROW ARTERIAL CATHETERIZATION KIT: 18 GA X 6"
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12388492
• Report Number: 9680794-2021-00434
• Device Sequence Number: 14352910
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: 50801902117644
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/16/2021

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: No Information
• Device Expiration Date: 02/28/2023
• Device Model Number: IPN036984
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 13F21C0852
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1