MAUDE Adverse Event Report: KARL STORZ SE&CO / KARL STORZ SE & CO. KG FETOSCOPIC LASER PHOTOCOAGULATION; AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES)

Model Number 11630KH

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Abdominal Distention (2601); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2023

Event Type  Death  

Event Description

A 35 yo g2p1001 at 19w4d with mo-di twins complicated by twin-to-twin transfusion syndrome, ttts stage iii and first trimester bleeding which led to a large subchorionic hematoma.Us findings for twin a , the recipient had reversed awave of the dvand the twin b , the donor had intermittent absent edf of the ua.The growth discordance was 18%.She underwent fetoscopic laser photocoagulation of placental anastomosis for ttts on (b)(6) 2023.The risk of her surgery was discussed in detail but that included further membrane separation that could lead to premature preterm rupture of membranes after the surgery.She was also at risk for placental abruption.At the same time if she did not perform surgery, she was at risk losing one or both twins.The surgery itself was uneventful.One pod#1 she was found to have significant amount of chorioamniotic separation.She was not leaking but later that afternoon she ruptured her membranes.She remained stable and the twins recovered from surgery with concordant fluid, bladder seen and normal dopplers.She resealed and reaccumulated fluid in both twins.She had latency antibiotics.However, at 22w1d, the days prior she had severe preeclampsia and underwent c-section for delivery of her twins.Twin b -former donor on day of life 10 became hemodynamically unstable with low pressure, abdominal distension with increased loops of bowel.X-ray noted to have pneumatosis.Abx was given.Received multiple transfusions of prbc, platelets, and ffp.Massive transfusion protocol initiated during pulmonary hemorrhage event and passed on dol 11.Ref report: mw5150227.

• Brand Name: FETOSCOPIC LASER PHOTOCOAGULATION
• Type of Device: AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ SE&CO / KARL STORZ SE & CO. KG; tuttlingen ; GM
• MDR Report Key: 18518585
• MDR Text Key: 332933820
• Report Number: MW5150228
• Device Sequence Number: 1
• Product Code: HFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 11630KH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White