MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SPRING WIRE GUIDE COMPONENT; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN036227
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the spring wire guide was kinking.Another spring wire guide was opened for use and also found to be kinking.The device was replaced.No patient harm or complication reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).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 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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
The complaint is reported as: the spring wire guide was kinking.Another spring wire guide was opened for use and also found to be kinking.The device was replaced.No patient harm or complication reported.The patient's condition is reported as fine.

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11569035
• Report Number: 9680794-2021-00129
• Device Sequence Number: 3660249
• Product Code: FOZ
• UDI-Device Identifier: 10801902122503
• UDI-Public: 10801902122503
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: No Information
• Device Expiration Date: 11/30/2023
• Device Model Number: IPN036227
• Device Catalogue Number: AW-04435
• Device Lot Number: 14F18M0189
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1