FDA.reportPublic FDA data

MAUDE MDR 9869460

MDR report key
9869460
Report number
1721279-2020-00059
Event key
0
Event type
3
Date of event
2019-07-11
Date received
2020-03-23
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
12020-03-2301. R

Event Narratives#

N

Patient 1

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

D

Patient 1

A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA. 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. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING TRACTION, WITH NO REPORTED PATIENT HARM. VEGETATION WAS NOTED ON BOTH OF THE LEADS AT THE TIME OF LEAD REMOVAL. USE OF THE BRIDGE BALLOON WAS NOT NECESSARY. WHEN THE BRIDGE BALLOON WAS REMOVED FROM THE BODY AFTER THE PROCEDURE, THE PHYSICIAN NOTED SIGNIFICANT THROMBUS FORMATION ON THE BRIDGE BALLOON. THREE DAYS POST PROCEDURE, THE PATIENT EXPERIENCED A PULMONARY EMBOLISM. THE MANUFACTURER BECAME AWARE OF THIS EVENT FROM A PHYSICIAN PRESENTATION AND FROM SUBSEQUENT CONVERSATIONS WITH THE PHYSICIAN AND MANUFACTURER.