MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-03-12 for TARGIS SYSTEM 410097-001 manufactured by Urologix, Inc.
[3354377]
Approximately a third of the way through treatment, it was detected by ultrasound that the anchor balloon had been leaking and not holding the 10cc's of water. The dr. Elected to pull the entire kit, rtu and catheter and start completely over with all new product.
Patient Sequence No: 1, Text Type: D, B5
[10550238]
The device history record for the catheter was reviewed; all manufacturing and quality assurance testing was carried out in accordance with standard procedures, and the device met specifications at the time of release. The catheter was returned for analysis. Visual inspection of the catheter confirmed that the location balloon was leaking not from the glue seams but a pressure puncture hole. Follow-up with the application specialist present for the treatment indicated that there was difficulty during insertion. However, the balloon was tested pre-treatment and was passing. Based on this information, it is likely that the location balloon was damaged during the insertion process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2013-00001 |
| MDR Report Key | 2999921 |
| Report Source | 06,07 |
| Date Received | 2013-03-12 |
| Date of Report | 2013-03-13 |
| Date of Event | 2013-01-21 |
| Date Mfgr Received | 2013-02-15 |
| Device Manufacturer Date | 2012-06-26 |
| Date Added to Maude | 2013-05-15 |
| 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 | MRS. HOPE PRZYBILLA |
| Manufacturer Street | 14405 21ST AVENUE N SUITE 110 |
| Manufacturer City | MINNEAPOLIS MN 554472000 |
| Manufacturer Country | US |
| Manufacturer Postal | 554472000 |
| Manufacturer Phone | 7634048134 |
| Manufacturer G1 | UROLOGIX, INC. |
| Manufacturer Street | 14405 21ST AVENUE N. SUITE 110 |
| Manufacturer City | MINNEAPOLIS MN 55447200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARGIS SYSTEM |
| Generic Name | MICROWAVE DELIVERY SYSTEM |
| Product Code | MEQ |
| Date Received | 2013-03-12 |
| Returned To Mfg | 2013-03-07 |
| Model Number | 410097-001 |
| Catalog Number | 410097-001 |
| Lot Number | 121024MCA1 |
| Device Expiration Date | 2014-09-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROLOGIX, INC |
| Manufacturer Address | 14405 21ST AVENUE N. SUITE 110 MINNEAPOLIS MN 55447200 US 55447 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-12 |