| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VIDA PTV CATHETER | BARD PERIPHERAL VASCULAR, INC. | OMZ | VDA100184 | UNK | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-12-10 | 0 | 1. D |
Patient 1
IT WAS REPORTED THAT POST A SUCCESSFUL PT VALVULOPLASTY PROCEDURE A PERICARDIAL LEAK WAS DIAGNOSED. THE PATIENT WAS SENT TO THE OPERATING ROOM, BTU EXPIRED DURING TRANSIT. THE CAUSE OF DEATH AND RELATIONSHIP TO THE DEVICE IS UNKNOWN AT THIS TIME.
Patient 1
A MANUFACTURING REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. THE RELATIONSHIP OF THE DEVICE TO THE DEATH IS UNKNOWN. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT.
Patient 1
TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. THIS FILE INDICATED ATTEMPTS WERE MADE TO THE FACILITY TO OBTAIN INFORMATION PERTAINING TO PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY). HOWEVER, AN EXPLANATION OF MISSING INFORMATION WAS NOT SUBMITTED TO THE FDA. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.