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

Model Number	A4E04
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report represents a combined initial and final report.Investigation summary: the event product was returned for evaluation.Upon inspection, engineering found the winding around the distal hole of the catheter came loose.This would lead to the balloon not inflating.The root cause of distal winding slip is most likely due to the unit being pushed/pulled with force in an inflated state within the vessel.The device is designed for a maximum pull force of 1.05 lbs; exceeding this value may result in winding slip.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.Additional information requested and received.
Event or Problem Description
Procedure performed: thrombectomy."when removing the python over the wire, we thought the python tip was unraveling.Physician ask for me to check for any malfunctions.I noticed the balloon had a hole and it wasn't inflating." additional info received: june 15, 2016.Balloon was inspected prior to the start of the procedure.No unraveling found on this catheter; only hole in balloon.

• 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: 6517232
• Report Number: 2027111-2017-01739
• Device Sequence Number: 13753519
• Product Code: DXE
• UDI-Device Identifier: 00607915113438
• UDI-Public: (01)00607915113438(17)200929(30)01(10)1255539
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K970762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2017

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: 09/29/2020
• Device Model Number: A4E04
• Device Catalogue Number: 100624101
• Device Lot Number: 1255539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1