MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-10 for TARGIS SYSTEM 410095-001 manufactured by Urologix, Inc..
[18254564]
It was reported that a catheter location balloon leak occurred during transurethral microwave treatment. The physician completed a treatement, but when they pulled the kit out after the case, they realized the balloon had leaked. There were no pain issues reported from the patient and the case was completed.
Patient Sequence No: 1, Text Type: D, B5
[18456672]
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. Research and development evaluation confirmed the leak between the location balloon and urine circuit. Although the location balloon leak was confirmed, the cause of the leak remains unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2012-00008 |
| MDR Report Key | 2780334 |
| Report Source | 05 |
| Date Received | 2012-10-10 |
| Date of Report | 2012-10-10 |
| Date of Event | 2012-09-14 |
| Date Mfgr Received | 2012-09-14 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-01-24 |
| 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 | MS. HOPE PRZYBILLA |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 554472000 |
| Manufacturer Country | US |
| Manufacturer Postal | 554472000 |
| Manufacturer Phone | 7634048134 |
| Manufacturer G1 | UROLOGIX, INC |
| Manufacturer Street | 14405 21ST AVENUE N |
| 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 FOR BPH |
| Product Code | MEQ |
| Date Received | 2012-10-10 |
| Returned To Mfg | 2012-09-25 |
| Catalog Number | 410095-001 |
| Lot Number | AHP061912A |
| Device Expiration Date | 2014-05-01 |
| 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 MINNEAPOLIS MN 55447200 US 55447 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-10 |