N
Patient 1
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
MAUDE MDR 8617219
- MDR report key
- 8617219
- Report number
- 1820334-2019-01186
- Event key
- 0
- Event type
- 3
- Date received
- 2019-05-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. LARRY POOL
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-16 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT DURING AN IVC FILTER RETRIEVAL PROCEDURE THE CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER EXPERIENCED A TUOHY-BORST HUB SEPARATION. THE FILTER WAS SUCCESSFULLY RETRIEVED BUT COULD NOT BE REMOVED THROUGH THE HUB OF THE DEVICE. AT THIS POINT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE RETRIEVAL SET AS WELL AS THE FILTER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT?S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OVERALL OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.