MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CE0480, 4F-80CM, SYNTEL RT-EMB; DXE

Model Number	15
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was requested and not received.The event unit was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause.The exact root cause remains unknown as the device was not returned for evaluation.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.  this retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Procedure performed unknown - "customer complained that the balloon burst during dilatation.Reportedly, the customer used 6 catheter during one procedure as each balloon burst.No samples available for return, discarded by the user facility.Customer = (b)(6)." patient status - "no patient injury reported.".

• Brand Name: CE0480, 4F-80CM, SYNTEL RT-EMB
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6382152
• Report Number: 2027111-2017-01374
• Device Sequence Number: 853421
• Product Code: DXE
• UDI-Device Identifier: 00607915117504
• UDI-Public: (01)00607915117504(17)191202(30)01(10)1235890
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: 15
• 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): 03/06/2017

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: 12/02/2019
• Device Model Number: 15
• Device Catalogue Number: 15
• Device Lot Number: 1235890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2015
• Initial Report FDA Received Date: 03/06/2017
• Patient Sequence Number: 1