MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG KARL STORZ; AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES)

Model Number 11630KF

Patient Problems Bradycardia (1751); Asystole (4442)

Event Date 02/27/2024

Event Type  Death  

Event Description

(b)(6) is a g1p0000 at 19w4d (estimated date of delivery: (b)(6) 2024) with mo-di twins complicated by ttts stage iii r.Twin a- recipient has reversed a-wave of the dv(dysfunctional voiding) and polyhydramnios and twin b--normal dopplers, no bladder seen.She had progressed fairly rapidly from the week prior where she did not meet criteria for ttts.After discussion and counseling she elected to proceed with fetoscopic laser photocoagulation of placental anastomosis.The procedure was performed on (b)(6) 2024.The procedure itself was uncomplicated and all vessels were identified and laser ablated.A total of 11 vascular connections were identified.Using a 600-micron laser fiber at a setting of 20-25 watts the diode laser was used to coagulate all vessels in a selective technique.A semi solemnization was performed in areas of the vascular equator in the middle of the placenta.A total of 190 pulses and 8.667 kilojoules and a laser time of 6:25 minutes were utilized.Periodically i reinspected the vascular equator from placenta edge to the other placenta edge with a 4mm 70-degree hopkins scope and felt like all the vessels and vascular connections were ablated at the end.An amnioreduction with a net negative of 760cc was performed.At the end of the case, the former recipient twin a was noted to have bradycardia which eventually ended with asystole.The former donor heart rate was normal at 133 bpm.Ref report # mw5152356.

• Brand Name: KARL STORZ
• Type of Device: AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG
• MDR Report Key: 18846656
• MDR Text Key: 337005992
• Report Number: MW5152357
• 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: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11630KF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White