MAUDE Adverse Event Report: TACTILE SYSTEMS TECHNOLOGY DBA TACTILE MEDICAL FLEXITOUCH SYSTEM; POWERED INFLATABEL TUBE MASSAGER

Model Number	PD32-U
Medical Device Problem Code	Delamination (2904)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the event, the surgeon advised the patient to refrain from device use over the breast area, but advised she may continue to use the device on the left arm.The surgeon believes the pneumatic compression device may have caused or contributed to the leak in the tissue expander.Patient chose not to continue treatment with the device and the device was returned to manufacturer.
Event or Problem Description
The patient has a history of left breast cancer resulting in mastectomy, lymph node removal, radiation and chemotherapy with diagnosis of post-mastectomy lymphedema syndrome.Patient is undergoing breast reconstruction and at the time of the event had a breast tissue expander in place as part of her phase one breast reconstruction.Patient was diagnosed with post-mastectomy lymphedema in her left arm and chest.Pt was prescribed the pneumatic compression device as part of her lymphedema treatment.Pt received the device on (b)(6) 2017 and was trained on in the on (b)(6) 2017.Patient used the device daily as prescribed without incident for approximately 10 weeks.On (b)(6), the patient noticed her left breast appeared smaller.Two days later, the surgeon re-filled the tissue expander (mentor #(b)(4)).The tissue expander again deflated the next day.The decision was made to expedite the surgical removal of the expander as it appeared to have a leak.There were no further reported complications.The patient will undergo breast reconstruction surgery as planned.
Event or Problem Description
The patient has a history of left breast cancer resulting in mastectomy, lymph node removal, radiation and chemotherapy with diagnosis of post-mastectomy lymphedema syndrome.Patient is undergoing breast reconstruction and at the time of the event had a breast tissue expander in place as part of her phase one breast reconstruction.Patient was diagnosed with postmastectomy lymphedema in her left arm and chest.Pt was prescribed the pneumatic compression device as part of her lymphedema treatment.Pt received the device on (b)(6) 2017 and was trained on the device on (b)(6) 2017.Patient used the device daily as prescribed without incident for approximately 10 weeks.On (b)(6), the patient noticed her left breast appeared smaller.Two days later, the surgeon re-filled the tissue expander (mentor #cpx4).The tissue expander again deflated the next day.The decision was made to expedite the surgical removal of the expander as it appeared to have a leak.There were no further reported complications.The patient will undergo breast reconstruction surgery as planned.

• Brand Name: FLEXITOUCH SYSTEM
• Common Device Name: POWERED INFLATABEL TUBE MASSAGER
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY DBA TACTILE MEDICAL; minneapolis MN
• MDR Report Key: 6745203
• Report Number: 3004183730-2017-00001
• Device Sequence Number: 817143
• Product Code: JOW
• UDI-Device Identifier: 00816305020106
• UDI-Public: 00816305020106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PD32-U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 79