MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-12-14 for PROLIEVE THERMODILITATION SYSTEM M0068808260 manufactured by Boston Scientific - Marlborough.
[21295778]
It was reported to boston scientific corporation (bsc) that a patient underwent a procedure with a prolieve thermodilatation kit for the treatment of benign prostatic hyperplasia (bph). It was reported that the thermal balloon did not deflate. According to the bsc sales representative, the physician reported he had difficulty deflating the thermal balloon. Follow up with the complainant revealed that at procedure closure when the physician went to deflate the compression balloon, it would not deflate. He then pulled out the catheter to remove it. He had to use a tamponade catheter to stop the bleeding. The catheter was in place for two days. The patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
[21537053]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2011-04181 |
| MDR Report Key | 2373974 |
| Report Source | 05,07 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-11-22 |
| Date of Event | 2011-06-22 |
| Date Mfgr Received | 2011-11-22 |
| Date Added to Maude | 2011-12-14 |
| 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 | EMP. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | ACCELLENT ENDOSCOPY JUAREZ |
| Manufacturer Street | 31C BUTTERFIELD TRAIL |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLIEVE THERMODILITATION SYSTEM |
| Generic Name | SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY |
| Product Code | MEQ |
| Date Received | 2011-12-14 |
| Model Number | M0068808260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-14 |