MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2008-08-05 for PERCUFLEX PLUS STENTS WITH HYDROPLUS COATING M0061752730 175-273 manufactured by Boston Scientific.
[20020485]
It was reported that prior to a ureteral stent placement procedure, a shaft kink occurred. Upon preparation of the percuflex plus ureteral stent, a kink located at the pigtail side hole was noted while advancing the device straightener to the distal pigtail portion of the stent. The device was not used during the procedure and another of the same device was used to complete the procedure. The patient's status is reported as "good".
Patient Sequence No: 1, Text Type: D, B5
[20111722]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-01368 |
| MDR Report Key | 1098686 |
| Report Source | 01,05,07 |
| Date Received | 2008-08-05 |
| Date of Report | 2008-07-08 |
| Date of Event | 2008-07-07 |
| Date Mfgr Received | 2008-07-08 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-04-28 |
| 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 | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | 780 BROOKSIDE DR. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUFLEX PLUS STENTS WITH HYDROPLUS COATING |
| Generic Name | PAD |
| Product Code | MER |
| Date Received | 2008-08-05 |
| Returned To Mfg | 2008-07-10 |
| Model Number | M0061752730 |
| Catalog Number | 175-273 |
| Lot Number | 11580660 |
| Device Expiration Date | 2012-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-05 |