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

Model Number	SMXP140RUH
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
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 (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 850cc artoura breast tissue expander would not inflate when removed from the box pre-operatively.During a breast reconstruction surgery, the physician stated that the tissue expander would not inflate to be implanted.No patient consequence or procedural delays were reported.
Additional Manufacturer Narrative
On january 18, 2021 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on february 9, 2021.Device evaluation summary: according to the information received, the artoura ss, t exp, uhp 850cc tissue expander would not inflate when removed from the box to be inflated and implanted.The product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.During the visual analysis of the returned sample, artoura ss, t exp, uhp 850cc no apparent damage or visual anomalies were observed.Leak testing was performed, in accordance with mentor procedures, and no difficulties to expand or leak sites were detected during the analysis.The event described could not be confirmed as the tissue expander was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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: 11157111
• Report Number: 1645337-2021-00334
• Device Sequence Number: 14354131
• Product Code: LCJ
• UDI-Device Identifier: 00081317024415
• UDI-Public: 00081317024415
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2020

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: 10/31/2022
• Device Model Number: SMXP140RUH
• Device Catalogue Number: SMXP140RUH
• Device Lot Number: 7648231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/18/2021; 02/09/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/08/2021; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1