MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0A11, STEALTH INSERT SZ 1 S/S 10/BX; DXC

Model Number	A0A11
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.There is no report of serious injury or death associated with this event.
Event or Problem Description
Procedure performed: unknown - "(on (b)(6) 2017: during procedure) a medical staff used the insert to occlude a vessel.The vessel occlusion was completed successfully.Then the medical staff tried to remove the insert from the vessel, the medical staff found that the rubber separated from the base.Please see the attached picture below.This event didn't affect the patient." type of intervention: na.Patient status: no health damage was reported for the patient.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult 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.

• Brand Name: A0A11, STEALTH INSERT SZ 1 S/S 10/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6408120
• Report Number: 2027111-2017-01545
• Device Sequence Number: 13581168
• Product Code: DXC
• UDI-Device Identifier: 00607915112967
• UDI-Public: (01)00607915112967(17)200831(30)01(10)1254225
• Combination Product (Y/N): N
• PMA/510(K) Number: K950492
• 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,Followup
• Report Date (Section B): 05/04/2017

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: 08/31/2020
• Device Model Number: A0A11
• Device Catalogue Number: 100735101
• Device Lot Number: 1254225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 05/04/2017
• Patient Sequence Number: 1