MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-10-29 for INTRABEAM BALLOON APPLICATOR 304534-7500-002 manufactured by Carl Zeiss Meditec Ag.
[19597995]
The initial reporter wsa present during the intraoperative radiotherapy procedure. The mfr investigated the process and rep samples. The site contact is: dr (b)(6), hosp.
Patient Sequence No: 1, Text Type: N, H10
[19695228]
During pt preparation following lumpectomy with sentinel node surgery and advance of intraoperative breast radiotherapy (iort), an intrabeam balloon applicator malfunctioned. Following applicator insertion into the tumor cavity and inflation with saline, the surgeon noticed the balloon was partially deflated due to tubing separation between the check valve and the luer fitting. The surgeon reinserted the tubing, deflated the balloon and removed the applicator from the tumor cavity. After checking applicator integrity and operation outside the body, the surgeon reinserted the applicator in the tumor cavity, reinflated the balloon with saline and proceeded with the iort procedure. The malfunction caused a procedural delay of approximately 5-10 minutes. The iort radiation source was not inserted at the time of malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2012-00014 |
| MDR Report Key | 2829905 |
| Report Source | 08 |
| Date Received | 2012-10-29 |
| Date of Report | 2012-10-29 |
| Date of Event | 2012-10-11 |
| Date Mfgr Received | 2012-10-11 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2013-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUDY BRIMACOMBE |
| Manufacturer Street | 5160 HACIENDA DR |
| Manufacturer City | DUBLIN CA 945687562 |
| Manufacturer Country | US |
| Manufacturer Postal | 945687562 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG |
| Manufacturer Street | CARL ZEISS STRASSE 22 |
| Manufacturer City | OBERKOCHEN 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Remedial Action | RC |
| 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 | 2012-10-29 |
| Catalog Number | 304534-7500-002 |
| Lot Number | 540960 |
| 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 STRASSE 22 OBERKOCHEN 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-29 |