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

Model Number FG-0201

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient is unknown, however, it was reported the patient was over 18 years.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device was disposed 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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a symphion resecting device was used during hysteroscopic myomectomy procedure performed on (b)(6) 2017.According to the complainant, the procedure went great and ended with no patient complications.Two hours after the patient was discharged, she was admitted to the emergency room due to bleeding and was taken to the operating room because of vomiting and pain.The physician performed hysteroscopy, laparoscopic ultrasound and laparotomy.Per physician's finding, the uterus was intact and there was no perforation noted.The patient is currently stable in the hospital.

Manufacturer Narrative

Additional information received via medwatch# mw5073157 on november 22, 2017.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a symphion resecting device was used during hysteroscopic myomectomy procedure performed on (b)(6) 2017.According to the complainant, the procedure went great and ended with no patient complications.Two hours after the patient was discharged, she was admitted to the emergency room due to bleeding and was taken to the operating room because of vomiting and pain.The physician performed hysteroscopy, laparoscopic ultrasound and laparotomy.Per physician's finding, the uterus was intact and there was no perforation noted.The patient is currently stable in the hospital.Additional information received on november 22, 2017.Patient underwent submucosal myomectomy with symphion bipolar device.No complications noted.No uterine perforation.Patient presented later with 1.5cm small bowel injury and enteric peritonitis.Energy of bipolar device escaped the intrauterine cavity and opened the small bowel through the uterine wall, without uterine perforation or direct contact of the bipolar device to the small bowel lack of uterine perforation was documented by no evidence of hysteroscopy.No acute loss of deficit on hysteroscopic fluid management; no sign of uterine perforation at the time of the laparotomy by general surgeon and assisting the general surgeon.Additional information received on december 13, 2017.It was reported that the patient has been discharged and is now okay.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE
• 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: 7005681
• MDR Text Key: 91200886
• Report Number: 3005099803-2017-03377
• Device Sequence Number: 1
• Product Code: PGT
• Combination Product (y/n): N
• 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,Followup
• Report Date: 10/19/2017

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 Expiration Date: 08/10/2018
• Device Model Number: FG-0201
• Device Lot Number: 62985255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 11/22/2017
• Supplement Dates FDA Received: 12/14/2017
• 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): Hospitalization; Required Intervention