FDA.reportPublic FDA data

MAUDE MDR 9875161

MDR report key
9875161
Report number
1721279-2020-00063
Event key
0
Event type
3
Date of event
2019-07-01
Date received
2020-03-24
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
MRS. BARBARA CREEL
Address
9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US
Phone
719-719-7194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETERBRIDGETHE SPECTRANETICS CORPORATIONMJN590-001590-001UNAVAILABLE N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2401. O

Event Narratives#

N

Patient 1

PATIENT DATE OF BIRTH UNAVAILABLE. PATIENT WEIGHT UNAVAILABLE. DEVICE LOT NUMBER, EXPIRATION DATE UNAVAILABLE. DEVICE MANUFACTURE DATE UNAVAILABLE BECAUSE DEVICE LOT NUMBER UNAVAILABLE.

D

Patient 1

PER THE REPORT RECEIVED FROM THE PHYSICIAN, A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) LEADS DUE TO REDUNDANCY AND NEED FOR AN UPGRADE. PRIOR TO THE PROCEDURE, A SPECTRANETICS BRIDGE OCCLUDING BALLOON WAS PROPHYLACTICALLY ''STAGED'' WITHIN THE PATIENT'S INFERIOR VENA CAVA (IVC). IN THE EVENT THAT AN EMERGENCY OCCURRED DURING THE PROCEDURE, THE BRIDGE BALLOON COULD THEN BE POSITIONED AND INFLATED WITHIN THE SUPERIOR VENA CAVA (SVC) TO PROVIDE OCCLUSION OF THE SVC AS A RESCUE MEASURE. ONE LEAD WAS REPORTED TO BE SUCCESSFULLY EXTRACTED; HOWEVER, THE ''OLD'' RV LEAD WAS CLEARLY ADHERED TO THE SEPTAL LEAFLET OF THE TRICUSPID VALVE, SO EXTRACTION OF THIS LEAD WAS DEFERRED. A THROMBUS WAS PRESENT ON THE RV LEAD WHICH THE PHYSICIAN NOTED AS UNUSUAL. USE OF THE BRIDGE BALLOON WAS NOT NECESSARY DURING THE LEAD EXTRACTION PROCEDURE. WHEN THE BRIDGE BALLOON WAS REMOVED FROM THE BODY AFTER THE PROCEDURE, THE PHYSICIAN NOTED A THROMBUS ON THE BRIDGE BALLOON. THERE WAS NO REPORTED PATIENT HARM. THE MANUFACTURER BECAME AWARE OF THIS EVENT FROM A PHYSICIAN PRESENTATION AND FROM SUBSEQUENT CONVERSATIONS WITH THE PHYSICIAN AND MANUFACTURER.