MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2009-02-25 for HYDRA JAGWIRE GUIDEWIRE M00556061 5606 manufactured by Boston Scientific Corporation-miami.
[1004815]
A hydra jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure, (patient age, gender, weight unknown) in 2007. According to the complainant, the coating peeled near tip during use". The device was removed and the procedure was completed successfully with another hydra jagwire. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8151629]
No impact or consequences to the patient. Peeling. User facility was unable to supply the correct lot number of the device used, consequently, the manufacture date of the device is unknown. The suspect device was not returned; therefore, a device evaluation is not available, and the cause of the reported coating peeled is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02707 |
| MDR Report Key | 1324898 |
| Report Source | * |
| Date Received | 2009-02-25 |
| Date of Report | 2007-05-29 |
| Date of Event | 2007-05-25 |
| Date Mfgr Received | 2007-05-29 |
| Date Added to Maude | 2009-02-25 |
| 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 | MR. 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 CORPORATION-MIAMI |
| Manufacturer Street | 8600 N.W. 41ST STREET |
| Manufacturer City | MIAMI FL 33166620 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33166 6202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRA JAGWIRE GUIDEWIRE |
| Generic Name | FDE |
| Product Code | FDE |
| Date Received | 2009-02-25 |
| Model Number | M00556061 |
| Catalog Number | 5606 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION-MIAMI |
| Manufacturer Address | 8600 N.W. 41ST STREET MIAMI FL 33166620 US 33166 6202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-25 |