MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3400, HANDLE MALLEABLE OCCLUSION SYS; DXC

Model Number	A3400
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2016
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Cags- "used the clamp to clamp aorta.Clamp kept coming loose and causing aorta to leak, changed to a reusable product to clamp aorta in preference to this product.Surgeon believes the handle is faulty and not securing properly.Didnt want to try a new handle at the time as didnt trust the clamp but wants the handle checked for fault." patient status- no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering observed that the clamp was rusted and there were signs of wear and damage on the locking mechanism.Testing was performed on the event unit and there were no signs of the clamp slipping or becoming loose.The root cause of the loose clamp could not be determined, as engineering was unable to replicate the complainant's experience.It is likely that the event unit was damaged due to improper care of the device, as rust and damage were observed on the event unit.Applied medical will continue to monitor its vigilance system and take appropriate actions as necessary to ensure the performance and safety of its products.

• Brand Name: A3400, HANDLE MALLEABLE OCCLUSION SYS
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6239300
• Report Number: 2027111-2016-00925
• Device Sequence Number: 13637090
• Product Code: DXC
• UDI-Device Identifier: 00607915110802
• UDI-Public: (01)00607915110802(11)280608(30)01(10)1199352
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K002915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: A3400
• Device Catalogue Number: 100574001
• Device Lot Number: 1199352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 05/11/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other