MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-26 for ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM 720340 AB2034 manufactured by Xoft, A Subsidiary Of Ican, Inc..
[3861747]
Patient underwent brachytherapy radiation treatment for breast cancer. While in route to the patient's home, the implanted balloon had ruptured. Patient returned to the physician's office where the physician replaced the ruptured 3-4 cm sized balloon with a 4-5 cm size balloon. It was observed that the balloon had split along its side. No serious injury was sustained by the patient, and the patient returned home after the balloon was replaced with no further incident. Internal tracking number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11107614]
Device failure analysis: the balloon of the device had a longitudinal tear along the seam or mold parting line. The failure mode is of the same failure signature as the balloon failures of previous mdr customer complaints filed under the following report numbers: 3005594788-2013-00001, 3005594788-2013-00002. Corrective action was initiated to effect several improvements in the manufacturer's process to reduce the occurrence of the balloon failures in the field. An investigation of the lot history record for the suspect part confirmed that the associated lot was produced in december 2011 and predated the implementation of the process refinements effected in 2013 by the corrective action.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2013-00005 |
| MDR Report Key | 3349807 |
| Report Source | 05,07 |
| Date Received | 2013-08-26 |
| Date of Report | 2013-08-26 |
| Date of Event | 2013-08-06 |
| Date Mfgr Received | 2013-08-06 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2013-11-26 |
| 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 | AL YOUNG |
| Manufacturer Street | 101 NICHOLSON LANE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4084931541 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BALLOON APPLICATOR |
| Product Code | JAD |
| Date Received | 2013-08-26 |
| Returned To Mfg | 2013-08-16 |
| Model Number | 720340 |
| Catalog Number | AB2034 |
| Lot Number | 820626 |
| Device Expiration Date | 2014-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAN, INC. |
| Manufacturer Address | SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-26 |