FDA Adverse Event
Malfunction
Summary report: N
2953200-2018-01130
MDR report key: 7746248
·
Received August 3, 2018
Report
- Report Number
- 2953200-2018-01130
- Event Type
- Malfunction
- Date Received
- August 3, 2018
- Date of Event
- July 13, 2018
- Report Date
- October 3, 2018
- PMA / PMN Number
- K050038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
A RELIANT BALLOON WAS BEING USED AS AN ACCESSORY DEVICE FOR AN UNKNOWN ENDOVASCULAR TREATMENT. DURING THE INDEX PROCEDURE IT WAS REPORTED, WHILE THE BALLOON WAS INSIDE THE STENT GRAFT IT RUPTURED WHILE BEING INFLATED FOR THE SECOND TIME. THE DEVICE WAS REPLACED BY ANOTHER MANUFACTURERS BALLOON TO COMPLETE THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO A DEFECTIVE PRODUCT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |