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.
Event or Problem Description
Paod - "from (b)(6), we continue get the compliant 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
Additional information was received.Investigation summary: the event unit was returned for evaluation.Engineering tested the balloon for inflation.The unit was observed under a microscope and a small pinhole was found in the balloon.A review of the manufacturing records for the lot number provided revealed that the product passed all quality and manufacturing inspections.All catheters undergo a 100% visual inspection and leak testing during production.The root cause is unknown; however, engineering believes the hole originated from conditions inside the vessel during insertion.The instructions for use (ifu) indicate, "balloon degradation and rupture may result from deposits within the vessel, excessive handling, or exposure to adverse environmental conditions." applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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 the supplemental report will be submitted to the fda.
Event or Problem Description
Additional information was received from the distributor on march 23, 2016: all the returned units were from the same hospital.The units were used on different patients, and by different doctors.The balloons were inspected or tested by inflation before being inserted in the patient.The products were inflated with a saline solution to the volume specified in the instructions for use (ifu).The returned units were used through a 6f introducer sheath.The vessel's condition was described as "stenosis." additional information received from the distributor on may 31, 2016: "this hospital is not a new account and don't use 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: 5386892
• Report Number: 2027111-2016-00068
• Device Sequence Number: 245306
• Product Code: DXE
• UDI-Device Identifier: 00607915113476
• UDI-Public: (01)00607915113476(17)200803(30)1(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): 12/14/2016

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: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1