MAUDE Adverse Event Report: APPLIED MEDICAL A4E08, PYTHON 13MM-80CM; DXE

Model Number	A4E08
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2015
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 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
Paod - "from (b)(6), we continue get the complaint about a4e08, the balloon broken or something (not sure what is it, very like silk?) shedding from the catheter." patient status - ok.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering noted that the proximal winding had partially unwound.The balloon was leak tested and measured, and the balloon met acceptance criteria.The root cause of the event is likely due to the unit being dragged against rough conditions.During the manufacturing process, all catheters are 100% leak tested and visually inspected prior to packaging.As stated in the instructions for use (ifu), "balloon degradation and rupture may result from deposits within the vessel, excessive handling, or exposure to adverse environmental conditions." although the root cause could not be confirmed, 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.In accordance with 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
Additional information received via email from distributor on january 5, 2016: "we already asked the customers for the dates, but they can't also verify it, and we also got the each 7 a4e08 at once." additional information received via email from distributor on march 23, 2016: all returned units are from the same hospital.All the returned units were used on different patients by different doctors.The balloons were inspected or tested for inflation before being inserted into the patient.The products were inflated with saline.The balloons were inflated to the volume according to the ifu.The returned units were used through introducer sheath with size 6f.The vessel was in stenosis condition.Additional information received via email from distributor on april 21, 2016: "the proximal winding [was] left inside the patient in the procedure." additional information received via email from distributor on april 27, 2016: "yes, it [the proximal winding was] successfully removed from the patient." additional information received via email from team member on june 1, 2016: "we contacted the distributor with the question below.They stated that this is not a new account from them and the surgeons are not using a new technique.".

• Brand Name: A4E08, PYTHON 13MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5386779
• Report Number: 2027111-2016-00074
• Device Sequence Number: 16223708
• Product Code: DXE
• UDI-Device Identifier: 00607915113476
• UDI-Public: (01)00607915113476(17)200803(30)01(10)1252636
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Followup
• Report Date (Section B): 01/04/2017

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: 08/03/2020
• Device Model Number: A4E08
• Device Catalogue Number: 100624501
• Device Lot Number: 1252636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2016
• Supplement Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1