MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-12 for TARGIS SYSTEM 410092-001 manufactured by Urologix, Inc.
[4370896]
During treatment, holes in balloon inflation port became evident.
Patient Sequence No: 1, Text Type: D, B5
[11729242]
Based on the initial location balloon failure reported, a follow-up call was placed with the urologix application specialist to obtain additional description of the failure. The application specialist stated that he had to keep filling the coolant bag throughout the treatment because of coolant leaking from a hole in the handle. He clarified that it was not the locating balloon. He further described that the coolant bag drained repeatedly and he kept refilling it. The dr. Had him change out the catheter and the treatment was completed. The tag indicated low coolant errors and 11 minutes of treatment time. Coolant was run through the catheter and the coolant leaked from a hole in the handle. Failure analysis included visual inspection and evaluation of the dye fill, resection of the location balloon and opening of handle valves. Failure analysis revealed coolant leaking from the coolant infill port into the location balloon through the handle. The leak path was created by an incomplete adhesive fill at the proximal-most annular handle fill. During a treatment, this handle cross-talk condition may have caused the location balloon to overfill and rupture, leading to a low pressure error. Although this failure mode may have caused a rupture in the location balloon, the system pressure monitor will sense this condition and cease microwave delivery almost immediately. Therefore, patient injury is unlikely to occur as a result of this condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2014-00002 |
| MDR Report Key | 3805650 |
| Report Source | 07 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-04-15 |
| Date Mfgr Received | 2014-04-15 |
| Device Manufacturer Date | 2013-08-15 |
| Date Added to Maude | 2014-06-25 |
| 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 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634048134 |
| Manufacturer G1 | UROLOGIX, INC. |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| 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 | 2014-05-12 |
| Returned To Mfg | 2014-04-28 |
| Model Number | 410092-001 |
| Catalog Number | 410092-001 |
| Lot Number | 121113MCA2 |
| Device Expiration Date | 2015-12-11 |
| 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 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-12 |