MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8301, S ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8301
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection was performed on the event unit and the complainant's experience of the ring separating from the sheath could not be confirmed.However, engineering found four (4) small holes and a large horizontal tear in the sheath.Based on the condition of the returned unit, it is likely that the tear was caused by an instrument that punctured the sheath during the procedure.The probability and criticality of harm resulting from this failure 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.This report represents the initial and final report.Based on the description of the event received, the event was deemed not reportable as it poses minimal risk to the patient.After evaluation, the event is deemed reportable.
Event or Problem Description
Event description: "the sheath was separated from the ring." additional information was received via email from sales manager, on thursday (b)(6) 2017: " the sheath on the white ring side was separated from the ring in places.The separated before use after unpacking.It was not inserted after noticing this." type of intervention: unknown patient status: "no patient injury.".

• Brand Name: C8301, S ALEXIS 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: 6985676
• Report Number: 2027111-2017-02092
• Device Sequence Number: 1228367
• Product Code: KGW
• UDI-Device Identifier: 00607915117207
• UDI-Public: (01)00607915117207(17)190112(30)01(10)1263157
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K041711
• 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
• Report Date (Section B): 10/27/2017

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: 01/12/2019
• Device Model Number: C8301
• Device Catalogue Number: 101355701
• Device Lot Number: 1263157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1