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

Model Number	A4E05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2017
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Thrombectomy-"(b)(4).The rupture/pinholes events occurred frequently lately in (b)(6)." "(on (b)(6) 2017: during a procedure) a thrombectomy was performed a python catheter was used for the surgery.The python catheter was ruptured when a medical staff tried to remove a thrombus from a blood vessel.No health damage was reported for the patient.Note: the python catheter was not used for artificial blood vessel." additional information received via email from distributor on january 17, 2017 - cers have already been submitted for other events.It was asked if balloon bursted/ruptured or if the balloon leaked as a result of a hole in the balloon.The response was that medical staff performed pre-operation check and no pinhole was confirmed at that time.The balloon did not occlude the vessel.There was no damage to the vessel.The catheter did not come into contact with any sharp objects throughout the procedure.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 confirmed the balloon had ruptured.There was no evidence of balloon fragmentation.It was observed that the thread around the balloon was frayed at the distal end.Based on the description of the event, the balloon was inspected prior to the procedure, which implies that the product was likely conformant before use.The frayed threading indicates the unit may have been dragged along adverse conditions within the vessel during use.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.

• 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: 6258963
• Report Number: 2027111-2017-00033
• Device Sequence Number: 426904
• 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): 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: 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: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• 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