MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E04, PYTHON 9MM-80CM; DXE

Model Number	A4E04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Engineering confirmed the complainant's experience of device breakage.The body of the tubing was damaged at the guide wire hub junction, which prevented the balloon from inflating.During inspection, the tip of the catheter broke off.Applied medical has reviewed the details surrounding the event and returned products.At this time, applied medical is unable to determine the root cause of the event.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this process, applied medical is currently researching possible process enhancements, which are intended to further minimize the likelihood for this type of event to occur.
Event or Problem Description
Procedure performed: "thrombectomy" "please see the attached report (b)(4) with pictures.On (b)(6) 2018: during a procedure [procedure: thrombectomy] the python catheter a4e04 was inserted into a patient's vessel.When a medical staff tried to inflate the balloon in the patient's vessel, the staff realized that the inflation tube was broken.The medical staff elected to remove the python catheter from the patient's vessel and use another python catheter for the surgery.The procedure was completed with no problem.This event didn't affect the patient.Comments from cosmotec: we confirmed the defective point where the connection area between inflation tube and guidewire hub.It's not sure that user performed prior checking (inspection) or not for the complaint sample.The user is heavy user of python catheter for a long time and the user is familiar with using python catheter.Investigation report for this case is required.The inflation tube is broken." type of intervention: "the medical staff elected to remove the python catheter from the patient's vessel and use another python catheter for the surgery.The procedure was completed with no problem." patient status: "this event didn't affect the patient.".

• Brand Name: A4E04, PYTHON 9MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7559169
• Report Number: 2027111-2018-00186
• Device Sequence Number: 1638104
• Product Code: DXE
• UDI-Device Identifier: 00607915113438
• UDI-Public: (01)00607915113438(17)211101(30)01(10)1281786
• Combination Product (Y/N): N
• PMA/510(K) Number: K970762
• 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
• Report Date (Section B): 05/31/2018

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: 11/01/2021
• Device Model Number: A4E04
• Device Catalogue Number: 100624101
• Device Lot Number: 1281786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 05/31/2018
• Patient Sequence Number: 1