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- Marlborough.
[1004788]
A hydra jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure (patient age, gender, weight unknown) in 2007. According to the complainant, during the procedure, a portion of the dream tip separated from the wire and the tip was successfully retrived from the bile duct. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8181122]
Removal of foreign body.. No impact or consequences to the patient. . Component detached. A visual evaluation of the returned device revealed, that the teflon sleeve and the hydrophilic coating was partially sliced off, exposing the core wire at approximately 5. 3 cm to 11. 2 cm from the dream end. Further examination under microscope at 30x magnification of the hydrophilic coating and the teflon sleeve showed smooth cut surfaces, suggesting that the guide wire probably made contact with a sharp object during the withdrawal of the unit, resulting in a partial detachment of the hydrophilic coating as well as the teflon sleeve. Directions for use (dfu) states do not use with metal-tip catheters. Withdrawing the guidewire through a metal tip catheter may damage the surface of the guidewire. Based on the investigation conducted, the most probable cause appears to be related to the use of a sharp object during the procedure which compromised the integrity of the hydrophilic coating (dream end) as well as the teflon sleeve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02795 |
| MDR Report Key | 1324940 |
| Report Source | * |
| Date Received | 2009-02-25 |
| Date of Report | 2007-07-23 |
| Date of Event | 2007-07-16 |
| Date Mfgr Received | 2007-07-23 |
| Device Manufacturer Date | 2007-04-30 |
| 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 |
| Returned To Mfg | 2007-08-03 |
| Model Number | M00556061 |
| Catalog Number | 5606 |
| Lot Number | 0009605063 |
| Device Expiration Date | 2010-04-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-25 |