MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-04-09 for AMPLATZ TYPE RENAL DILATOR M0062601010 260-101 manufactured by Boston Scientific Corporation.
[1096078]
It was reported to boston scientific corporation that a renal dilator was inspected during preparation for a percutaneous nephrolithotomy procedure. According to the complainant, the tip of the device was found to be bent. The bend was visible through the package and there was no damage to the packaging. The physician completed the procedure with another renal dilator without patient complications. The patient condition following the procedure was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
[8291797]
The device has been received, but an evaluation has not yet been performed. Therefore, a failure analysis is not available and we have not yet determined the relationship between this device and the cause for this failure. If there is any further relevant information, a supplemental manufacturer's report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-01639 |
| MDR Report Key | 1434637 |
| Report Source | 05,07 |
| Date Received | 2009-04-09 |
| Date of Report | 2009-03-24 |
| Date of Event | 2009-03-24 |
| Date Mfgr Received | 2009-03-24 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2009-09-09 |
| 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 | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| 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 | AMPLATZ TYPE RENAL DILATOR |
| Product Code | GCC |
| Date Received | 2009-04-09 |
| Returned To Mfg | 2009-04-03 |
| Model Number | M0062601010 |
| Catalog Number | 260-101 |
| Lot Number | 11786827 |
| Device Expiration Date | 2012-06-09 |
| 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 CORPORATION |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-09 |