MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E01, PYTHON 5MM-40CM; DXE

Model Number	A4E01
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine 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.The complaint sample is not available for investigation, however, we would like you to issue credit for this case.Event description: "on (b)(6) 2018: during a procedure [procedure: thrombectomy], the python catheter a4e01 was used for the surgery.The python catheter was ruptured when a medical staff tried to remove a thrombus from a blood vessel.Another package of python catheter was opened and used for the surgery.The procedure was completed with no problem.No health damage was reported for the patient.Comments from (b)(4): complaint sample was not returned from the hospital because the sample was discarded at hospital.The balloon was inspected prior to use for the surgery.According to the user, they didn't apply excessive pressure to the balloon.Investigation report for this case is required.Additional information was received via email on 15.May.2018 from (b)(4), distributor.The balloon did not occlude the vessel."the surgeon removed the ruptured catheter, then the surgeon elected to use another python catheter to continue the surgery.The procedure completed without any problem." there was no damage to the vessel."according to the report by the user, no." the catheter did not come into contact with any sharp objects throughout the procedure."according to the report by the user, no." the surgeon did not have any difficulty inserting or removing the catheter.The balloon "according to the report, it was most likely "tear/cut"." no unintended material was left in the patient.Type of intervention: "another package of python catheter was opened and used for the surgery.The procedure was completed with no problem." patient status: "no health damage was reported for the patient.".

• Brand Name: A4E01, PYTHON 5MM-40CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7580925
• Report Number: 2027111-2018-00200
• Device Sequence Number: 1698149
• Product Code: DXE
• UDI-Device Identifier: 00607915113407
• UDI-Public: (01)00607915113407(17)220402(30)01(10)1291497
• 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): 06/07/2018

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: 04/02/2022
• Device Model Number: A4E01
• Device Catalogue Number: 100623801
• Device Lot Number: 1291497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/07/2018
• Patient Sequence Number: 1