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

Catalog Number 50-401XL

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Edema (2020); Tachycardia (2095); Abdominal Distention (2601); Hypervolemia (2664)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.The disposable 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 not able to be conducted for the myosure system as the identification numbers were not provided by the complainant.Reference internal complaint: (b)(4).

Event Description

Note: this report pertains to the second of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report# 1222780-2015-00182.It was reported during a myosure procedure for uterine tissue removal on (b)(6) 2015, there was a fluid deficit of 6500ml using saline.The patient exhibited signs of hypervolemia which included distended abdomen, tachycardia and pulmonary edema.The procedure was aborted and the patient was administered 40mg of lasix.The patient passed fluid, is ok and was discharged home.

• 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: callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5156887
• MDR Text Key: 28562256
• Report Number: 1222780-2015-00183
• 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: Physician
• Report Date: 09/18/2015

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: 50-401XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention