FDA.reportPublic FDA data

MAUDE MDR 8577746

MDR report key
8577746
Report number
3005099803-2019-02322
Event key
0
Event type
3
Date of event
2019-04-01
Date received
2019-05-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1SEAL BIOPSY VALVEBIOPSY VALVEBOSTON SCIENTIFIC CORPORATIONOCXSBC-580-1002095-02R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-030

Event Narratives#

N

Patient 1

THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). ACCORDING TO THE COMPLAINANT IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

D

Patient 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BIOPSY CAP POPPED OFF FROM THE BIOPSY PORT OF THE SCOPE CAUSING FLUIDS TO SPRAY EVERYWHERE. THEY WERE ABLE TO COMPLETE THE CASE WITH THIS DEVICE. THERE WAS NO SERIOUS INJURY NOR ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.