Definition: Call For PMAs 12/30/87 (52 FR 36883 10/1/87))
| Device Type ID | 3977 |
| Device Name | Transcervical Contraceptive Tubal Occlusion Device |
| Regulation Description | Contraceptive Tubal Occlusion Device (TOD) And Introducer. |
| 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 | PMA |
| CFR Regulation Number | 884.5380 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | HHS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3977 |
| Device | Transcervical Contraceptive Tubal Occlusion Device |
| Product Code | HHS |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Contraceptive Tubal Occlusion Device (TOD) And Introducer. |
| CFR Regulation Number | 884.5380 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7753 |
Migration | 1950 |
Insufficient Information | 1458 |
Biocompatibility | 1139 |
Break | 904 |
Patient-Device Incompatibility | 289 |
Migration Or Expulsion Of Device | 145 |
Expulsion | 107 |
Difficult To Remove | 102 |
Device Appears To Trigger Rejection | 102 |
Device Dislodged Or Dislocated | 73 |
Device Operates Differently Than Expected | 69 |
Coil | 68 |
Appropriate Term/Code Not Available | 63 |
Difficult To Insert | 53 |
Malposition Of Device | 42 |
Separation Failure | 35 |
Material Fragmentation | 25 |
Extrusion | 24 |
Material Twisted / Bent | 22 |
Activation Failure Including Expansion Failures | 20 |
Positioning Failure | 19 |
Difficult Or Delayed Positioning | 17 |
Catheter | 17 |
Unexpected Therapeutic Results | 16 |
Device Or Device Fragments Location Unknown | 16 |
Detachment Of Device Or Device Component | 16 |
Bent | 15 |
Entrapment Of Device | 14 |
Positioning Problem | 11 |
Improper Or Incorrect Procedure Or Method | 11 |
Sticking | 10 |
Detachment Of Device Component | 9 |
Fracture | 9 |
Product Quality Problem | 8 |
Stretched | 8 |
Material Perforation | 7 |
Device Damaged By Another Device | 7 |
Therapeutic Or Diagnostic Output Failure | 7 |
Unraveled Material | 6 |
Failure To Advance | 6 |
Material Separation | 6 |
No Pressure | 6 |
Material Protrusion / Extrusion | 4 |
Defective Device | 4 |
Occlusion Within Device | 4 |
Metal Shedding Debris | 3 |
Difficult To Position | 3 |
Device Slipped | 3 |
Split | 3 |
Component Falling | 3 |
Loose Or Intermittent Connection | 2 |
Failure To Disconnect | 2 |
Difficult To Advance | 2 |
Premature Activation | 2 |
Mechanical Problem | 2 |
Spring | 2 |
Unintended Movement | 2 |
Physical Resistance / Sticking | 2 |
Material Deformation | 2 |
Degraded | 2 |
Capturing Problem | 2 |
Activation, Positioning Or Separation Problem | 2 |
Tip | 2 |
Use Of Device Problem | 2 |
Defective Component | 2 |
Device Inoperable | 2 |
Device Deployer | 2 |
Uncoiled | 2 |
Physical Resistance | 1 |
Failure To Adhere Or Bond | 1 |
Contamination During Use | 1 |
Over-Sensing | 1 |
Guidewire | 1 |
Failure To Fire | 1 |
Material Integrity Problem | 1 |
Low Impedance | 1 |
Material Puncture / Hole | 1 |
Component Missing | 1 |
Obstruction Of Flow | 1 |
Structural Problem | 1 |
Misfire | 1 |
Electromagnetic Compatibility Problem | 1 |
Material Frayed | 1 |
Wire | 1 |
Premature Discharge Of Battery | 1 |
Explosion | 1 |
Loss Of Osseointegration | 1 |
Arcing | 1 |
Chemical Spillage | 1 |
Device Handling Problem | 1 |
Failure To Power Up | 1 |
Folded | 1 |
Inadequate Or Insufficient Training | 1 |
Under-Sensing | 1 |
Out-Of-Box Failure | 1 |
False Negative Result | 1 |
Tube | 1 |
Ring | 1 |
Microbial Contamination Of Device | 1 |
| Total Device Problems | 14778 |