MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE REACH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 10-401FC

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are 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.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.2 devices were involved in this event and are reported under : 1222780-2021-00287.

Event Description

It was reported that on (b)(6) 2021, after a myosure procedure that involved a myosure reach and a myosure xl to remove a calcified fibroid, the procedure went without incidents and had a final deficit of 1600ml ; the patient continued bleeding after the procedure, using two pads in the last hour.Physician decided to administer 1 g of tranexamic acid (txa) 1 g intravenously , the patient continued to heavily bleed and the physician administered methergine and cytotec (misoprostol).The patient´s bleeding slowed but continued.The physician consulted about the possibilty of performing an ablation to stop the bleeding which was considered an off-label use.No other information is available.

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 12616665
• MDR Text Key: 275944363
• Report Number: 1222780-2021-00286
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• 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
• Report Date: 10/12/2021

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: No Information
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/12/2021
• 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 XL
• Patient Outcome(s): Other