MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E05, PYTHON 11MM-40CM; DXE

Model Number	A4E05
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: "thrombectomy." event description: "please see report '(b)(4)'.When medical staff tried to remove thrombus, the balloon was ruptured.The medical staff elected to remove the python catheter from the patient's vessel and use competitor's catheter for the surgery.This event didn't affect the patient." "complaint sample was discarded in the hospital because the patient has infection.The complaint sample is not available for investigation." additional information was received via email from regulatory affairs and quality assurance, on tuesday 19-dec-2017 "according to the sales rep., the balloon rupture issue is the same as (b)(6)." type of intervention: "use competitor's catheter for the surgery" patient status: "this event didn't affect the patient.".
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.

• Brand Name: A4E05, PYTHON 11MM-40CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7181236
• Report Number: 2027111-2018-00014
• Device Sequence Number: 1237242
• Product Code: DXE
• UDI-Device Identifier: 00607915113445
• UDI-Public: (01)00607915113445(17)180102(30)01(10)1181977
• 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,Followup
• Report Date (Section B): 01/19/2018

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: 01/02/2018
• Device Model Number: A4E05
• Device Catalogue Number: 100624201
• Device Lot Number: 1181977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 01/19/2018
• Patient Sequence Number: 1