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 november, 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
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed that the proximal winding had slipped which was likely due to the device being pulled against a rough surface (when the balloon was inflated).It was determined that the risk associated with this incident is acceptable and that the risk levels remain the same.During the manufacturing process all catheters are thoroughly inspected and tested.Applied medical continually seeks to improve the form, function and ease of use of its products and as part of this process, 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 to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, a supplemental report will be submitted to the fda.
Event or Problem Description
Additional information received via email from customer, march 23, 2016: the returned units were not all from the same hospital.The returned units were used on different patients.The returned units were used by different doctors.The balloons were inspected and tested by insufflation before being inserted into the patient.The products were inflated with saline.The balloons were inflated according to the ifu.The returned units were used through the introducer sheath.The introducer sheath was 6f.The vessel had stenosis.Additional information received via email from customer, april 21, 2016: "the proximal winding left inside the patient in the procedure." additional information received via email from customer, april 27, 2016: the proximal winding was successfully removed from the patient.

• 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: 5386915
• Report Number: 2027111-2016-00075
• Device Sequence Number: 322439
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other