Definition: Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding
| Device Type ID | 4070 |
| Device Name | Intrauterine Tamponade Balloon |
| Physical State | The Device Consists Of A Catheter With A Balloon At The Distal End. The Balloon Is Distended To Achieve Tamponade Or Reduction Of Post Partum Uterine Bleeding. |
| Technical Method | The Clinician Passes The Balloon Through The Vagina And Cervix Into The Uterus. Then, He/she Distends The Balloon And Closely Monitors The Patient's Bleeding. |
| Target Area | Uterus, Cervix, Vagina |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.4530 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4070 |
| Device | Intrauterine Tamponade Balloon |
| Product Code | OQY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARGON MEDICAL DEVICES, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CLINICAL INNOVATIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 24 |
Balloon | 17 |
Fluid Leak | 14 |
Material Rupture | 12 |
Inflation Problem | 11 |
Deflation Problem | 8 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Break | 3 |
Stopcock | 2 |
Loss Of Or Failure To Bond | 2 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Catheter | 1 |
Device Operates Differently Than Expected | 1 |
Burst Container Or Vessel | 1 |
Port | 1 |
Crack | 1 |
Blocked Connection | 1 |
Detachment Of Device Or Device Component | 1 |
Separation Problem | 1 |
Device Damaged Prior To Use | 1 |
Partial Blockage | 1 |
Hole In Material | 1 |
Off-Label Use | 1 |
Installation-Related Problem | 1 |
| Total Device Problems | 112 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Clinical Innovations, LLC | II | Oct-15-2015 |
| 2 | Clinical Innovations, LLC | II | Jan-27-2015 |