MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E04, PYTHON 9MM-80CM; DXE

Model Number	A4E04
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Thrombectomy - "while performing a thrombectomy procedure a python a4e04, lot # 1276316 was placed arterially over a wire.Wire was then removed to perform an arteriogram via the python.We imaged to check our placement and noticed that the distal tip of the python was not attached to the shaft of the catheter.The tip moved to the distal bifurcation of the ulnar radial artery.[doctors] were able to retrieve the tip with a snare." patient status: no patient injury.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation with twenty-seven (27) sterile units.Upon visual inspection, engineering confirmed that the tip (balloon, proximal and distal windings) had separated from the catheter of the event unit.Testing was performed on the sterile units and all units met current specifications.It is likely that the event unit was inflated and pulled with a force exceeding what the balloon was able to withstand or was subjected to adverse conditions within the vessel.The instructions for use (ifu) states "balloon degradation and rupture may result from exposure to adverse environmental conditions, excessive handling, or deposits within the vessel." 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
Add info received via email from user facility on april 3, 2017 - there was no resistance when the guidewire was being removed.The guidewire was not re-inserted at any point after performing the arteriogram.No energy devices(monopolar/bipolar) were utilized during the procedure.

• Brand Name: A4E04, PYTHON 9MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6366504
• Report Number: 2027111-2017-01421
• Device Sequence Number: 10930931
• Product Code: DXE
• UDI-Device Identifier: 00607915113438
• UDI-Public: (01)00607915113438(17)210816(30)01(10)1276316
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K970762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: Other
• Device Expiration Date: 08/16/2021
• Device Model Number: A4E04
• Device Catalogue Number: 100624101
• Device Lot Number: 1276316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1