MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2009-02-26 for HYDRA JAGWIRE GUIDEWIRE M00556021 5602 manufactured by Boston Scientific Corporation- Marlborough.
[1030304]
A hydra jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography procedure, on a female patient (patient age, and weight unknown) in 2008. According to the complainant, while accessing the ampulla and bile duct at the site of the wire where the 10cm hydrophilic dream tip meets the shaft of the jagwire body, the black hydrophilic tip became separated from the body of the wire. This resulted in a ridge that made cannulation challenging, and also made the "under wire" (the non coated part of the wire) visible. The physician noticed this and removed the wire from the scope. The procedure was completed with another hydra jagwire guidewire. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8178943]
Removal of foreign body. No impact or consequences to the patient. Component, detachment of. A visual evaluation performed on the returned device revealed, that the poly tip separated from the flare exposing approximately 8 mm of the core wire. The entire poly tip is present and in tact. The polyurethane tip is still adhered to the core wire and there is evidence showing that the poly flowed (migrated) into the teflon slip (flare). Damage to the ptfe jacket flare and proximal poly end was noted. There is also damage noted to the ptfe jacket. The damage is located approximately 7. 5 cm- 8 cm measuring from the flare. The poly tip was cut in order to determine if the polyurethane tip has moved. The core wire is within the poly with only approximately 1 mm of poly extending over the core wire itself. The damage noted to the ptfe jacket may have occurred during retrieval of the torquing device. Thus causing the damage noted to the poly proximal end and flare. This is based on the evidence presented by the wire. The customer did not indicated that the condition was noted prior to use. The most probable cause of the failure may be due to the wire coming in contact with an object or instrument upon retrieval of the wire.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-03391 |
| MDR Report Key | 1325759 |
| Report Source | * |
| Date Received | 2009-02-26 |
| Date of Report | 2008-02-05 |
| Date of Event | 2008-02-05 |
| Date Mfgr Received | 2008-02-05 |
| Device Manufacturer Date | 2008-01-03 |
| Date Added to Maude | 2009-02-26 |
| 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 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 | DDE |
| Product Code | FDE |
| Date Received | 2009-02-26 |
| Returned To Mfg | 2008-02-14 |
| Model Number | M00556021 |
| Catalog Number | 5602 |
| Lot Number | 0011379807 |
| Device Expiration Date | 2011-01-02 |
| 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 | 2009-02-26 |