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 2009-02-25 for HYDRA JAGWIRE GUIDEWIRE M00556051 5605 manufactured by Boston Scientific Corporation- Marlborough.
[1004919]
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 the physician notice that the "jagtip wire was missing", he completed the procedure using only the dream tip of the wire. After the procedure, the physician tried to locate the missing coating tip, but was unable to find it in the patient and thought that may be the coating was missing during unpacking. The procedure was completed with the same hydra jagwire guide device no patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8153565]
No impact or consequences to the patient - component, detachment an evaluation of the suspected device revealed that the jag end of the guidewire had detached due to torsional overload and the fracture site exhibited no deformities or material reduction. Also the fracture surface exhibited elongated dimpled ruptures in a torsional direction. The corewire was sent to the analytical lab to the determine if the fracture had occurred and the cause of it. The analysis revealed that the fracture surface exhibited elongated dimpled ruptures in a torsional direction. No other material anomalies were noted. During the manufacturing procedures the units are inspected 100% at several stations along the production line, verifying the presence of the jag end and its integrity. Units that do not comply with these criteria are rejected. All units are packaged appropriately in order to protect the device from external damage during shipment. A review of the manufacturing record for this particular batch shows that the device met its material, assembly and product specifications at the time of its release to distribution and found no nmrb's (non conforming material review) that could be related to the reported failure. The root cause for this reported issue has been determined as handling damage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02714 |
| MDR Report Key | 1324905 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-02-25 |
| Date of Report | 2007-05-29 |
| Date of Event | 2007-05-29 |
| Date Mfgr Received | 2007-05-29 |
| Device Manufacturer Date | 2007-02-08 |
| 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 | 2007-06-13 |
| Model Number | M00556051 |
| Catalog Number | 5605 |
| Lot Number | 0009395119 |
| Device Expiration Date | 2010-02-06 |
| 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 |