MAUDE Adverse Event Report: TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL FLEXITOUCH PLUS SYSTEM; PNEUMATIC COMPRESSION DEVICE

Model Number	PD32-G3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had a history of chronic dvt's and was using pneumatic compression devices for many years without incident, chronic dvt's are not a contraindication to the flexitouch plus system.While using the flexitouch plus product the patient developed an acute dvt which resulted in a pe.The prescribing physician of the flexitouch plus stated the device did not cause the dvt, but it may have contributed to it dislodging part of the clot behind my knee.The device performed as intended, there were no device defects reported by the user.The patient had discontinued use of the product due to her newly diagnosed acute dvt's.
Event or Problem Description
The patient received a pd32-g3 controller, serial number (b)(4); a full leg short left garment 3l-fl-sh-l lot 20027; a full leg short right garment 3l-fl-sh-r lot 20006 and a trunk small 3a-tr-sm-a lot 603250 on (b)(6) 2020 and began using it on (b)(6) 2020.Patient performed prescribed protocol of l1, bilateral simultaneous lower extremity treatment with normal pressure, one time per day.During the first week of (b)(6) 2020, patient reported feeling symptoms of sluggishness and shortness of breath.Patient stated, on (b)(6) 2020 they came up from their basement and could not catch their breath which led them to go the emergency department at doctor's community hospital, (b)(6) where they were then admitted.Patient discharged to home on (b)(6) 2020.The patient was diagnosed with bilateral pe blood clots and a deep vein thrombosis behind the knee in the popliteal region of the right lower extremity.The patient was prescribed anticoagulation therapy for a minimum of three months.While at the emergency department, patient was diagnosed and treated by dr.(b)(6), emergency medicine md, (b)(6).The patient's pcp, dr.(b)(6), internist, is the prescriber of the product.The patient stated, ''dr (b)(6) said the device did not cause the dvt, but it may have contributed to it dislodging part of the clot behind my knee and travelling to the lung.'' patient confirmed the discovery of the dvt behind the knee was made at admission to the hospital note: patient has history of rle chronic dvt's.Dr.(b)(6) advised the patient to stop using the product.

• Brand Name: FLEXITOUCH PLUS SYSTEM
• Common Device Name: PNEUMATIC COMPRESSION DEVICE
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL; 151 5th avenue nw; new brighton,
• MDR Report Key: 10388789
• Report Number: 3004183730-2020-00001
• Device Sequence Number: 14156579
• Product Code: JOW
• UDI-Device Identifier: 00816305021400
• UDI-Public: 00816305021400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring,Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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-G3
• Device Catalogue Number: PD32-G3
• Device Lot Number: 20027, 20006, 603250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/10/2020
• 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: Hospitalization
• Patient Age: 61 YR
• Patient Weight: 116