MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0801, 33MM INSERT S/T 10/BX; DXC

Model Number	1
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 the investigation.
Event or Problem Description
Open aneurysm repair, fem-popliteal bypasses, carotid endarterectomy - "falls apart during procedure" applied medical received additional information from the customer on may 2, 2017 via email.The light blue insert is the component that detached, it did not fall into patient, but onto sterile field prior to handing to md.The customer was not informed by the staff that the user experienced loss of occlusion, just that inserts are not staying in the clamp.The insert was used with fogarty arterial clamps angled and straight.The insert come in contact with any sharp instruments and appeared to be intact.Type of intervention: unknown.Patient status: not at this time.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed damage to both the distal and proximal attachment buttons of the traction insert.No damage was observed on the soft insert.Based on the condition of the returned unit and additional information received from the complainant, it is likely that the reported event was caused by a combination of the injection molding process and the non-applied clamp that was used during the procedure.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.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: A0801, 33MM INSERT S/T 10/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6567341
• Report Number: 2027111-2017-01753
• Device Sequence Number: 11025142
• Product Code: DXC
• UDI-Device Identifier: 00607915113360
• UDI-Public: (01)00607915113360(17)210831(30)01(10)1278643
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: 08/31/2021
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1278643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 08/18/2017
• Patient Sequence Number: 1