FDA.reportPublic FDA data

MAUDE MDR 8084603

MDR report key
8084603
Report number
3005099803-2018-61432
Event key
0
Event type
3
Date of event
2018-10-01
Date received
2018-11-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CAROLE MORLEY
Address
300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAPTIVATOR COLD SINGLE-USE SNARESNARE, NON-ELECTRICALBOSTON SCIENTIFIC CORPORATIONFGXM00561101R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-190

Event Narratives#

N

Patient 1

DATE OF EVENT WAS APPROXIMATED TO BE (B)(6) 2018, AS NO EVENT DATE WAS REPORTED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. PROBLEM CODE (B)(4) CAPTURES THE REPORTABLE EVENT OF SNARE LOOP RETRACTED SUDDENLY/UNEXPECTEDLY. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR ROUND COLD SNARE WAS TO BE USED IN A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SNARE LOOP WAS EXTENDED, THE METAL GROMMET EXTENDED OUT OF THE SHEATH. WHEN THE NURSE OR THE TECHNICIAN WAS TRYING TO CLOSE THEIR HAND TO CUT THE TISSUE, INSTEAD OF HAVING A SMOOTH CUTTING PROCESS, THE GROMMET HUNG UP ON THE SHEATH AND WHEN ENOUGH FORCE WAS EXERTED ON THE HANDLE, THE SNARE LOOP RETRACTED SUDDENLY/UNEXPECTEDLY.