MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E08, PYTHON 13MM-80CM; DXE

Model Number	A4E08
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the balloon had ruptured.Applied medical has reviewed the details surrounding the event and returned products.At this time, applied medical is unable to confirm the root cause of the event.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.
Event or Problem Description
Procedure performed: "thrombectomy" event description: the python catheter a4e08 was inspected prior to the start of the procedure and the balloon was inflated successfully.When a medical staff tried to inflate the balloon in the patient's vessel, the balloon was ruptured easily.The medical staff elected to remove the python catheter from the patient's vessel and use another python catheter a4e06 for the surgery.The procedure was completed with no problem.*it's not sure that the patient's vessel was calcified or not this event didn't affect the patient.*the catheter is not decontaminated the balloon is broken." type of intervention: "use another python catheter a4e06 for the surgery.The procedure was completed with no problem." patient status: "this event didn't affect the patient.No health damage was reported for the patient.".

• Brand Name: A4E08, PYTHON 13MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7382086
• Report Number: 2027111-2018-00123
• Device Sequence Number: 1103725
• Product Code: DXE
• UDI-Device Identifier: 00607915113476
• UDI-Public: (01)00607915113476(17)211020(30)01(10)1281784
• 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): 03/29/2018

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: 10/20/2021
• Device Model Number: A4E08
• Device Catalogue Number: 100624501
• Device Lot Number: 1281784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1