MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number UNK891

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

Patient Problem Pain (1994)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device has been disposed of and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a genesys hydrothermablation procerva procedure set and a symphion fluid management accessories device were used during a uterine hydrothermablation (hta) procedure performed on (b)(6) 2016.According to the complainant, during hysteroscopy with the genesys hta device, the physician noted that the patient¿s uterus appeared scarred and contained a lot of clot-like material.The physician was unable to visualize neither the tubal ostia nor the fundus due to the clots.The physician then transitioned to using the symphion device to resect out the clot material.Within 5 minutes, the symphion system¿s 3-liter saline bag was empty.The physician halted the procedure to account for the lost fluid.800 ml of fluid from the genesys hta device and 1700 ml of fluid from the symphion device could not be accounted for.A laparoscopic examination of the abdominal cavity was performed and there was no fluid or evidence of a uterine perforation.The physician prescribed toradol and norco for pain management.Post-procedure imaging was performed and no fluid was identified within the patient¿s abdomen or inside the uterus.It was noted that the patient¿s uterus appeared to be ¿big¿.There were no further patient complications reported as a result of this event.The patient¿s condition was reported to be fine.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5996089
• MDR Text Key: 56349542
• Report Number: 3005099803-2016-03015
• Device Sequence Number: 1
• Product Code: PGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141848
• 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: 09/09/2016

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: Health Professional
• Device Model Number: UNK891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/04/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR