MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8402, M ALEXIS O WND PROT/RET 5/BX; KGW

Model Number	3
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: thoracotomy.Event description: sheath tore.It was reported that the facility is not sure how the tear occurred.No metal retractors were used over the device.The surgeon has used the alexis for a thoracotomy procedure previously without incident.No patient injury.No additional information regarding the location of the tear nor the timing of the tear during the procedure.No additional information regarding how the tear occurred or how the procedure was completed.Type of intervention: na.Patient status - no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.A visual inspection was performed on the event unit.However, the complainant's experience could not be confirmed.Engineering received additional information from the complainant which verified that the unit returned had an outer ring malfunction.Based on the condition of the returned unit, it is likely the reported event was caused by retractor deployment process.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.
Event or Problem Description
Additional information was received via email on august 11, 2017 from the territory manager (tm): the clinical coordinator and the tm were not present for the case.The event device was already bagged the following day when the tm arrived.It is unknown how the tear occurred.It is unknown what instrumentation, if any, were used at the time of the tear.The location of the tear is unknown.Additional information was received via email on august 18.2017 from clinical development: it was reported that there was no tear in the sheath."when they tried to roll the white ring down, the white ring would not stay put." the customer has used the alexis protector before.

• Brand Name: C8402, M ALEXIS O WND PROT/RET 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6793279
• Report Number: 2027111-2017-01932
• Device Sequence Number: 19078572
• Product Code: KGW
• UDI-Device Identifier: 00607915117269
• UDI-Public: (01)00607915117269(17)191020(30)01(10)1280728
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: 3
• 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): 10/03/2017

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: 10/20/2019
• Device Model Number: 3
• Device Catalogue Number: 3
• Device Lot Number: 1280728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1