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

Model Number	A4E08
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Although the complaint was received for a broken balloon, engineering was unable to confirm the complainant's experience.Engineering did note that the proximal winding thread had slipped off from the proximal marker band.Applied medical has reviewed the details surrounding the event and returned products.At this time, applied medical is unable to determine the root cause of the event.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
Procedure performed: "embolectomy"."we continue receive the complaint, the balloon broken, and not fill in the suggest volume.Some of them are found broken in pre-test, others broke during surgery procedure.Inject volume with broken: 1.5cc.We receive a series of complaint python a4e08 device.Balloons broke during pre-test or surgery procedure.Users said they didn't over injection liquid or gas, and the balloons broke before suggest volume." additional information was received via email from product specialist on thursday 21jun2018.Regarding the questions, users usually pre-test the balloon by normal saline or gas.After pre-test, balloon keep uninflated until it is used for the patient.If a catheter with balloon broken during pre-test or procedure and will be replaced by a new one.According to the report from users, they didn't mentioned vessel damage and unintended material left in the patient.We will try to get more information about this issue.Type of intervention: na.Patient status: na.

• Brand Name: A4E08, PYTHON 13MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7773193
• Report Number: 2027111-2018-00250
• Device Sequence Number: 11257795
• Product Code: DXE
• UDI-Device Identifier: 00607915113476
• UDI-Public: (01)00607915113476(17)220827(30)01(10)1303211
• 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: Initial
• Report Date (Section B): 08/10/2018

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: 08/27/2022
• Device Model Number: A4E08
• Device Catalogue Number: 100624501
• Device Lot Number: 1303211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1