MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E06, PYTHON 11MM-80CM; DXE

Model Number	A4E06
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: "thrombectomy" event description: on (b)(6) 2018: during a preparation for procedure [procedure: thrombectomy].The python catheter a4e03 was opened.During pre-use check: when a medical staff tried to inflate the balloon in the patient's vessel, the staff found leak around inflation tube.The medical staff realized that the inflation tube was broken.The medical staff elected to use another python catheter a4e06 for the surgery.During pre-use check: when the medical staff tried to inflate the balloon, the balloon was ruptured.The medical staff elected to use another device and the procedure was completed with no problem.This event didn't affect the patient." comments from (b)(6): complaint sample was returned from the hospital.The sample will be returned to applied medical.Investigation report for this case is required.Type of intervention: "the medical staff elected to use another device and the procedure was completed with no problem." patient status: "this event didn't affect the patient.".
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.

• Brand Name: A4E06, PYTHON 11MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7631626
• Report Number: 2027111-2018-00210
• Device Sequence Number: 1818961
• Product Code: DXE
• UDI-Device Identifier: 00607915113452
• UDI-Public: (01)00607915113452(17)220104(30)01(10)1284924
• 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 Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: Other
• Device Expiration Date: 01/04/2022
• Device Model Number: A4E06
• Device Catalogue Number: 100624301
• Device Lot Number: 1284924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1