MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for HOLOGIC CONTURA 4.5CM MULTILUMEN BALLOON B11345 manufactured by Hologic, Inc..
[68127031]
A hologic contura balloon applicator for hdr breast brachytherapy was found to have questionable channel problems after it was inserted into a pt. The 5 channel applicator was discovered to have the inherent radiopaque marker on channel 4 rather than being on channel 1. This resulted in an inconsistency between the identification of the channels on the brachytherapy treatment plan and the mfr's labeling on the applicator. The plan was delivered to the pt for one of 10 planned fractions before this was identified. The applicator was then removed from the pt by the attending physician. Only one treatment was delivered. Visual inspection of the applicator confirmed the marker was on channel 4. The result is that the delivered radiation dose to the pt was rotated from planned dose distribution by 90 degrees. The plan was recalculated to match how it was treated. The actual dose to the pt differed from the planned dose by less than 20% for the target volume and all organs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068016 |
| MDR Report Key | 6349266 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-02-06 |
| Date of Event | 2017-01-30 |
| Date Added to Maude | 2017-02-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HOLOGIC CONTURA 4.5CM MULTILUMEN BALLOON |
| Generic Name | CONTURA 4-5CM MULTILUMEN BALLOON |
| Product Code | JAQ |
| Date Received | 2017-02-17 |
| Returned To Mfg | 2017-02-08 |
| Model Number | B11345 |
| Lot Number | REHT1037 |
| Device Expiration Date | 2018-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-17 |