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

Model Number	TEXP135RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2020
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: na.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 500cc artoura breast tissue expander being used for a primary breast reconstruction deflated intraoperatively.A healthcare professional reported that there was a hole on the expander that was not near the suture line.The hole was noticed during the implantation surgery, and the device had touched the patient.However, at this time of report, no patient consequences or procedural delays were reported due to the deflation.The implantation surgery was completed with using an unspecified mentor device.If additional information is received in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
On 23-jun-2020, the suspected medical device was returned for evaluation.On 1-jul-2020, the investigation on the suspected medical device was completed.Investigation summary: during the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, according to mentor procedure, and it revealed that there was an area of missing material on anterior view, measuring approximately 0.1 cm x 0.1 cm.Microscopic examination of the edges of the missing material revealed parallel striations that are consistent with markings made by a sharp instrument perforating silicone material.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 10121113
• Report Number: 1645337-2020-06895
• Device Sequence Number: 13915179
• Product Code: LCJ
• UDI-Device Identifier: 00081317009481
• UDI-Public: 00081317009481
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 05/15/2020

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: 07/11/2021
• Device Model Number: TEXP135RH
• Device Catalogue Number: TEXP135RH
• Device Lot Number: 7476254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1