FDA Adverse Event
Malfunction
Summary report: N
BALLOON APPLICATOR KIT - 4-5 SPHERICAL
MDR report key: 1022883
·
Received March 28, 2008
Report
- Report Number
- 3005594788-2008-00001
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 8, 2008
- Manufacturer
- XOFT, INC.
- Product Code
- JAQ
- PMA / PMN Number
- K050843
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BALLOON LEAK DURING BRACHYTHERAPY OF THE BREAST IS AN ANTICIPATED EVENT. THE BALLOON IN THIS EVENT WAS EVALUATED INCLUDING A REVIEW OF THE DHR, VISUAL INSPECTION, AND SEM IMAGES OF THE MATERIAL. ONGOING EVALUATION TO DETERMINE THE BALLOON'S LEAK ROOT CAUSE IS RECOMMENDED. THIS PRODUCT IS PART OF AN IRB APPROVED STUDY AND OCCURRED AT A CLINICAL INVESTIGATION SITE. PT WAS NOT HARMED.
Description of Event or Problem · 1
A 4-5 CM SPHERICAL BALLOON LEAKED AFTER IT WAS INFLATED TO APPROX 45 CC. THE BALLOON WAS REMOVED AND SENT TO XOFT FOR EVALUATION. INCIDENT DID NOT RESULT IN A PT INJURY. BALLOON RUPTURE IS AN ANTICIPATED ADVERSE EVENT PER THE INSTRUCTIONS FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BALLOON APPLICATOR KIT - 4-5 SPHERICAL | BALLOON APPLICATOR | JAQ | XOFT, INC. | NA | 800025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |