MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	TEXP110RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: not applicable - device leaked intraoperatively manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 455cc artoura breast tissue expander began leaking during a primary breast reconstruction.The device was opened on the surgical table and slightly filled; however, the device began to leak.At the time of this report, there is no evidence of a need for additional surgical intervention, but a supplemental report will be sent if additional information is received.
Additional Manufacturer Narrative
On march 26, 2020, a manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's reference number: (b)(4).

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9824504
• Report Number: 1645337-2020-03132
• Device Sequence Number: 11219625
• Product Code: LCJ
• UDI-Device Identifier: 00081317009535
• UDI-Public: 00081317009535
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: TEXP110RUH
• Device Catalogue Number: TEXP110RUH
• Device Lot Number: 7652169-048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1