MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8322, XS ALEXIS WND PROT/RET SHRT 5/BX; KGW

Model Number	C8322
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.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
Procedure performed: unk."the sheat attachment peeled off from the ring approximate size 1-2 cm." "our customer mistakenly thrown the actual used product, so we can`t return for inspection." additional information was received via email on 21jun2018 from, (b)(4), distributor."the incident occur after placement of the product, while the doctor tried to roll up the sheath." type of intervention: unk.Patient status: unk.

• Brand Name: C8322, XS ALEXIS WND PROT/RET SHRT 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7701083
• Report Number: 2027111-2018-00232
• Device Sequence Number: 19149768
• Product Code: KGW
• UDI-Device Identifier: 00607915132958
• UDI-Public: (01)00607915132958(17)201010(30)01(10)1308093
• Combination Product (Y/N): N
• 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): 07/18/2018

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: 10/10/2020
• Device Model Number: C8322
• Device Catalogue Number: 101432501
• Device Lot Number: 1308093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/18/2018
• Patient Sequence Number: 1