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

Model Number	A4E05
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of tip separation.Based on the condition of the returned unit, the reported event was caused by a material change, which made the device more susceptible to uv light.The probability and criticality of harm resulting from this failure have been reviewed and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented material and process enhancements intended to further minimize the potential for this type of event to occur.
Event or Problem Description
Procedure performed: embolectomy.The catheter broke during treatment.The doctor didn't feel a lot of resistance when removing catheter.Please refer to enclose for pictures and videos for this event.Patient status: no patient injury.Type of intervention: unknown.

• 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: 8511922
• Report Number: 2027111-2019-00422
• Device Sequence Number: 1767580
• Product Code: DXE
• UDI-Device Identifier: 00607915113445
• UDI-Public: (01)00607915113445(17)230308(30)01(10)1320036
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: Health Professional
• Device Expiration Date: 03/08/2023
• Device Model Number: A4E05
• Device Catalogue Number: 100624201
• Device Lot Number: 1320036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1