MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN036444
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the doctor didn't have any issue advancing the wire but when he tried to advance the introducer over the wire it felt like it was getting hung up and caught.He tried several times to advance, bending the catheter and introducer in the process in the attempt.Another kit was pulled and a new wire introducer and catheter was attempted to be placed with the same results.A triple lumen kit was pulled and catheter placed without any problems.No patient harm or injury reported.The patient's condition was reported as critical, unrelated to the device.
Event or Problem Description
The complaint is reported as: the doctor didn't have any issue advancing the wire but when he tried to advance the introducer over the wire it felt like it was getting hung up and caught.He tried several times to advance, bending the catheter and introducer in the process in the attempt.Another kit was pulled and a new wire introducer and catheter was attempted to be placed with the same results.A triple lumen kit was pulled and catheter placed without any problems.No patient harm or injury reported.The patient's condition was reported as critical, unrelated to the device.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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 MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11679713
• Report Number: 1036844-2021-00059
• Device Sequence Number: 3149841
• Product Code: FOZ
• UDI-Device Identifier: 30801902116834
• UDI-Public: 30801902116834
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• 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): 03/24/2021

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: 05/31/2021
• Device Model Number: IPN036444
• Device Catalogue Number: CDC-21242-X1A
• Device Lot Number: 23F20D0131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1