MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Model Number 50-501XL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/14/2018

Event Type  Death  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant; therefore, the expiration date is not known.The device is not being returned; therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant; therefore, the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.Internal complaint reference: (b)(4).

Event Description

It was reported that on (b)(6) 2018 a myosure tissue removal procedure with aquilex fluid management was performed.Prior to the myomectomy the physician performed a laparoscopic salpingectomy.According to the clinical account manager, "there was fluid on the floor so the gyn coordinator did a manual count which was 2100cc." "the procedure went along as normal and upon leaving the patient's vital signs were all normal." the clinical account manager received a call on (b)(6) 2018 from the gyn coordinator to report that the patient was found unresponsive at home on (b)(6) 2018 and was transported to the emergency room and subsequently expired.The presumptive diagnosis was pulmonary embolism which was ultimately confirmed on autopsy.Additional information received on (b)(6) 2018 reported that the patient was unable to have a bowel movement for 5 days post operatively and called the physician.She spoke with a partner of the physician and was advised to use a suppository.The autopsy report determined multiple pulmonary emboli in the chest.Based on follow-up the medical director's judgement is that the myosure xl and aquilex systems did not cause or contribute to a serious injury nor does the information indicate a malfunction of either device that would be likely to cause or contribute to this event.Pelvic surgery of any type can lead to pe but the risk of pe is not directly related to the device(s) used.

• Brand Name: MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 8180959
• MDR Text Key: 130898277
• Report Number: 1222780-2018-00257
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/19/2018
• 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: Initial
• Patient Sequence Number: 1
• Treatment: MYOSURE CONTROL UNIT: SN UNKNOWN
• Patient Outcome(s): Death
• Patient Age: 41 YR