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

Model Number	SMXP130RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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.Reason for device explant and/or reoperation: not applicable.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 475cc artoura breast tissue expander experienced deflation on an unspecified side intra operatively.Per physician, when trying to fill expander it did not hold any fluid.No procedural delays or patient consequence was reported.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 10/13/2020.Device evaluation summary: according to the information reported, a deflation occurred in a tissue expander.During the visual evaluation of the device, no apparent damage or anomalies were observed.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
It was discovered on (b)(6) 2020, that device available for evaluation? no, is device returned to manufacturer? unchecked, date device returned to manufacturer was erroneously omitted in initial report.Correction: device available for evaluation?,yes is device returned to manufacturer? checked, date device returned to manufacturer (b)(6)2020.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: 10588696
• Report Number: 1645337-2020-12156
• Device Sequence Number: 16853107
• Product Code: LCJ
• UDI-Device Identifier: 00081317024316
• UDI-Public: 00081317024316
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2020

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: 10/16/2023
• Device Model Number: SMXP130RH
• Device Catalogue Number: SMXP130RH
• Device Lot Number: 9379699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 09/25/2020; 10/13/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 09/25/2020; 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1