MAUDE Adverse Event Report: HOLOGIC, MARLBORUGH MA MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was not able to be conducted for the myosure system as the identification numbers were not provided by the complainant.If additional relevant information is received, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported a physician performed a successful myosure procedure for uterine tissue removal in conjunction with a thermachoice heat ablation (not a hologic device) on (b)(6) 2015.The patient was discharged home.Approximately a week later the patient presented to the doctors office and was "septic".We have been unable to obtain additional information surrounding this event.

Manufacturer Narrative

This supplement is for the initial mfr report #: 1222780-2015-00211.Reference internal complaint: (b)(4).

Event Description

On (b)(6) 2015 additional information was received and it was reported the patient was admitted into the hospital on (b)(6) 2015 and discharged on (b)(6) 2015.Antibiotics were administered intravenously.Blood cultures were drawn and the patient is "doing fine now".

Manufacturer Narrative

Response to fda request letter received on (b)(6) 2016: additional information was received and it was reported the patient was admitted into the hospital on (b)(6) 2015 and discharged on (b)(6) 2015.Antibiotics were administered intravenously.Blood cultures were drawn and the patient is "doing fine now".Additional information was received and it was reported the patient was admitted into the hospital on (b)(6) 2015 and discharged on (b)(6) 2015.Antibiotics were administered intravenously.Blood cultures were drawn and the patient is "doing fine now".I spoke with the hologic vp medical affairs to further discuss event and the sepsis could be related to myosure, but could also be related to thermalchoice (not a hologic device) procedure.The myosure disposable device was not returned.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.No new additional information provided.Internal reference complaint#: (b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, MARLBORUGH MA; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 5247564
• MDR Text Key: 32068445
• Report Number: 1222780-2015-00211
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2015

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
• Device Operator: Physician
• Device Catalogue Number: 10-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/11/2015; 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MYOSURE HYSTEROSCOPE-SERIAL NUMBER UNK
• Patient Outcome(s): Other