N
Patient 1
(B)(6).
MAUDE MDR 9865325
- MDR report key
- 9865325
- Report number
- 2134265-2020-03686
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-10
- 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
- JAY JOHNSON
- Address
- TWO SCIMED PLACE MAPLE GROVE MN 55311 US
- Phone
- 763-763-7634
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EQUALIZER | CATHETER, PERCUTANEOUS | BOSTON SCIENTIFIC CORPORATION | MJN | 20280 | 20280 | 0024552389 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-23 | 12 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AORTA-ILIAC. DURING THE PROCEDURE, AN EQUALIZER 33/7/2/100 BALLOON CATHETER WAS ADVANCED FOR DILATATION. AFTER THE STENT GRAFT WAS PLACED, TOUCH-UP WAS PERFORMED WITHOUT A PROBLEM FROM THE AORTA TO THE LEG FROM THE LEFT SIDE FEMORAL. NEXT, AFTER DILATION WAS PERFORMED, WHEN TOUCH-UP WAS PERFORMED FROM THE RIGHT SIDE FEMORAL WITH THE USE OF THE SAME BALLOON, NEGATIVE PRESSURE WAS APPLIED, BUT DEFLATION COULD NOT BE PERFORMED. THE 20CC SYRINGE WAS CHANGED TO 10CC SYRINGE IN FIRST INFLATION AND WAS ABLE TO PERFORM THE DEFLATION SLOWLY FOR FOUR TO FIVE MINUTES MANUALLY AND SALINE CONTRAST RATIO WAS APPROXIMATELY 50:50. THIS WAS ATTEMPTED THREE TIMES USING THE SAME SIZE, 33MM, AND 27MM ALL HAD THE SAME ISSUE. EVENTUALLY, TOUCH-UP WAS PERFORMED USING GORES CODA BALLOON AND WAS ABLE TO DEFLATE WITH NO RESISTANCE FELT. THE CAUSE WAS NOT CONFIRMED SINCE THE BLOOD VESSEL WAS RELATIVELY STRAIGHT ANATOMICALLY. MOREOVER, THERE SHOULD BE NO RESISTANCE FELT SINCE THE SHEATH WAS FOR STENT GRAFT AND THE LUMEN WAS THICK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.