MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E02, PYTHON 5MM-80CM; DXE

Model Number	11
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated the device could also be from lot 1225034; manufacture date 16jun2014, expiration date 15jun2019, udi: (b)(4).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
Removing blood clots - "(during a clinical use on (b)(6) 2015) the catheter was used to remove blood clots in a bypass vessel at below knee.There was no problem with the balloon when it was checked before use, however; the balloon ruptured when it was inflated in patient's blood vessel.The amount of saline was good.Perhaps the calcified vessel caused the rupture.One of the above lots was considered based on the shipping history.(b)(4)." patient status - "no patient injury.".

• Brand Name: A4E02, PYTHON 5MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6382145
• Report Number: 2027111-2017-01376
• Device Sequence Number: 10881173
• Product Code: DXE
• UDI-Device Identifier: 00607915113414
• UDI-Public: (01)00607915113414(17)181209(30)01(10)1209218
• Combination Product (Y/N): N
• PMA/510(K) Number: 11
• 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 a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/09/2018
• Device Model Number: 11
• Device Catalogue Number: 11
• Device Lot Number: 1209218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2015
• Initial Report FDA Received Date: 03/06/2017
• Patient Sequence Number: 1