MAUDE Adverse Event Report: AMR A0803, 86MM INSERT S/T 10/BG; DXC

Model Number	A0803
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2016
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
Discovered prior to surgery - "inserts are not staying on the clamps.Medline complaint #: (b)(4), medline part #: 05945." from medline: "we were notified of a complaint from a customer stating that the inserts are falling of the fogarty clamps.The samples were received for investigation and without the clamps the reported concern could not be confirmed.The returned samples were measured and compared to the samples that were pulled from our inventory.Both sets contain the same measurement.We would like your help to determine if the samples are to your specifications.If you would like the samples return for investigation please provide a call tag.Please reference below complaint number in future communication." additional information received june 7, 2016: "q.Can you please provide us with the customer information? a.Unfortunately, that is proprietary information.Q.Please confirm the quantity involved.When you say ?both sets,? do you mean 4 total? a.There is a total of 4 two that the customer returned and two that we pulled from our stock to compare the measurements.Q.Please confirm the date that the incident occurred.A.It was reported on (b)(6) 2016.Q.When was the incident detected? were the inserts being used in a patient at the time? a.The incident happen prior to patient use.Q.If it was during a procedure, what procedure was being performed? a.N/a.Q.Did the surgeon experience loss of occlusion due to the detachment? a.Prior to surgery.Q.Was there any damage to the vessel? a.No damage.Q.What type of intervention was required? a.Replaced the inserts with sterile versions off their shelfs.Q.Were the inserts able to be retrieved from the patient? a.Prior to surgery.Q.Please provide the patient status.A.No patient injury.".
Additional Manufacturer Narrative
Investigation summary: the event unit was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Although the root cause of the event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.

• Brand Name: A0803, 86MM INSERT S/T 10/BG
• Common Device Name: DXC
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5776829
• Report Number: 2027111-2016-00495
• Device Sequence Number: 13608600
• Product Code: DXC
• UDI-Device Identifier: 00607915113391
• UDI-Public: (01)00607915113391(17)190716(30)01(10)1227412
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K883790
• 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): 05/03/2017

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: 07/16/2019
• Device Model Number: A0803
• Device Catalogue Number: 100520801
• Device Lot Number: 1227412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2016
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1