MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2009-02-26 for HYDRA JAGWIRE GUIDEWIRE M00556071 5607 manufactured by Boston Scientific Corporation-miami.
[1129490]
Note: this report is a supplement to manufacturer report #3005099803-2008-3248.
Patient Sequence No: 1, Text Type: D, B5
[8395482]
Corrected data: should be: unknown was: yes.
Patient Sequence No: 1, Text Type: N, H10
[15446792]
An hydra jag device was used during an est procedure performed in 2007 (patient age, gender and weight unknown). According to the complainant, during the procedure, the physician "attempted to place some stents to inhibit arterial hemorrhage with tamponade of apc and balloon. The guidewire was inserted into bile duct and used delivery system to place the 7. 5fr erbd. However, it was unable to go through the hydra jag and found that the coating of hydra jag was accordion. Also the delivery system was deformed". The scope being used and the generator, both devices manufacturers are unknown. Reportedly, the procedure was completed with another hydra jag device. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[15568371]
No impact or consequences to the patient. Twisting - device defective. User facility was unable to supply the correct lot number of the device used; consequently, the expiration date of the device is unknown. An evaluation of the device revealed, that the teflon was bunched together and indented towards the dream end. Approximately 16 cm of the exposed wire was inside the catheter. Also the teflon was cut at two locations 21 cm from the jag end flare. The cut teflon may have been caused by a sharp edge, and the bunched teflon may have occurred when the wire were inserted against resistance. It also appears that that the outer coating of the guidewire was torn and accordion causing the advancement of the delivery device to be impossible. The potential root cause of this failure mode is likely due to the delivery system and the stent damage caused by user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-03248 |
| MDR Report Key | 1325655 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-02-26 |
| Date of Report | 2007-11-27 |
| Date of Event | 2007-11-27 |
| Date Mfgr Received | 2009-03-16 |
| Date Added to Maude | 2009-05-27 |
| 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. 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-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 | 2009-02-26 |
| Model Number | M00556071 |
| Catalog Number | 5607 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-02-26 |