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

Model Number	A4E05
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Applied medical has just received the event device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: "thrombectomy" another python catheter (lot#1181977) was returned from hospital because the customer suspected the balloon quality defect.We also will return the catheter to applied medical, so please investigate it too." event description: on (b)(6) 2017: during a procedure [procedure: thrombectomy] when medical staff tried to remove thrombus, the balloon was raptured.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." type of intervention:"the medical staff elected to remove the python catheter from the patient's vessel and use competitor's catheter for the surgery." patient status: "no health damage was reported for the patient.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Upon visual inspection, engineering observed a slit in the balloon near the proximal winding.There was also fraying on the proximal winding.Based on the condition of the returned unit and the description of the event, it is likely that balloon breakage occurred when the balloon came into contact with a rough surface during use.The instructions for use (ifu) states "balloon degradation and rupture may result from deposits within the vessel, excessive handling, or exposure to adverse environmental conditions".The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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: 7366046
• Report Number: 2027111-2018-00121
• Device Sequence Number: 1949607
• 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): 04/12/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1