MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-10-04 for INTRABEAM BALLOON APPLICATOR 304534-7500-002 manufactured by Carl Zeiss Meditec Ag.
[18845087]
During preparation for breast intraoperative radiotherapy following a lumpectomy, an intrabeam balloon applicator malfunctioned. The balloon applicator had been inserted in the tumor cavity, inflated with saline, deflated and then removed from the tumor cavity for repositioning. While outside the body, the applicator separated at a point between the luer fitting and the check valve. The applicator was replaced with another one from the same lot and the intraoperative radiotherapy proceeded with minimal delay. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[19059033]
The initial reporter was present during the intraoperative radiotherapy procedure. There was a preliminary evaluation of the malfunctioned device at the site. An investigation is underway. The site contact is: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2012-00012 |
| MDR Report Key | 2778127 |
| Report Source | 08 |
| Date Received | 2012-10-04 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-09-17 |
| Date Mfgr Received | 2012-09-10 |
| Date Added to Maude | 2013-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUDY BRIMACOMBE |
| Manufacturer City | DUBLIN CA 945687562 |
| Manufacturer Country | US |
| Manufacturer Postal | 945687562 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG |
| Manufacturer Street | CARL-ZEISS- STR. 22 |
| Manufacturer City | OBERKOCHEN 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRABEAM BALLOON APPLICATOR |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2012-10-04 |
| Catalog Number | 304534-7500-002 |
| Lot Number | 54906 |
| Device Expiration Date | 2013-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Manufacturer Address | CARL-ZEISS-STR. 22 OBERKOCHEN 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-04 |