MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-01-18 for E-Z GLIDER 35BX manufactured by Circon Surgitek.
[160776]
During a procedure to remove a kidney stone, the ureter was pierced by the guidewire. The pt was taken to the operating room to repair the ureter and remove the stone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-2000-00001 |
| MDR Report Key | 259355 |
| Report Source | 05 |
| Date Received | 2000-01-18 |
| Date of Report | 1999-12-15 |
| Date Mfgr Received | 1999-12-15 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2000-01-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CAROLYN DE JONGE |
| Manufacturer Street | 609 BEECHWOOD RD. |
| Manufacturer City | WILLOW GROVE PA 19090 |
| Manufacturer Country | US |
| Manufacturer Postal | 19090 |
| Manufacturer Phone | 2156581655 |
| Manufacturer G1 | CIRCON SURGITEK |
| Manufacturer Street | 3037 MT. PLEASANT ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-Z GLIDER |
| Generic Name | COATED URETRAL GUIDEWIRE |
| Product Code | EYA |
| Date Received | 2000-01-18 |
| Model Number | NA |
| Catalog Number | 35BX |
| Lot Number | 642589J |
| ID Number | NA |
| Device Expiration Date | 2004-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 251169 |
| Manufacturer | CIRCON SURGITEK |
| Manufacturer Address | 3037 MT. PLEASANT ST. RACINE WI 53404 US |
| Baseline Brand Name | E-Z GLIDER GUIDEWIRE |
| Baseline Generic Name | URETERAL GUIDEWIRE |
| Baseline Catalog No | 35BX |
| Baseline ID | .035", 150CM, S |
| Baseline Device Family | HYDROPHILIC COATED GUIDEWIRE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-01-18 |