MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-09-12 for PT GRAPHIX GUIDE WIRE UNK manufactured by Boston Scientific.
[528276]
It was reported that following a coronary stent procedure, the patient coded. The lesion was located in the calcified left anterior descending (lad) artery. The physician advanced a 6f vl 3. 5 runway guide catheter into the left main. A choice floppy 300cm guide wire was placed across the lesion in the proximal lad. A 3mm x 16mm taxus drug eluting stent was deployed in the ostial lad. This stent partially jailed the circumflex and intermediate ramus. The pt graphix 300cm guide wire was advanced across the intermediate ramus. The intermediate ramus was dilated with a 2. 0 x 9 maverick otw balloon catheter. The pt graphix wire was removed from the intermediate ramus and placed in the lad. The lad was dilated with a 3. 0 x 9 maverick otw balloon catheter. A new pt graphix 300cm guide wire was placed in the circumflex. The guides were exchanged with the pt graphix guide wires in place. The physician placed a. 035 wire in the aorta for support. The pt graphix wire in the circumflex traveled distal to the pericardium (this was not noticed during the procedure). Plaque was no longer visible in the intermediate ramus. The physician utilized a kissing technique using a 3. 0 x 9 maverick otw balloon catheter and a 3. 5 x 12 taxus drug eluting stent which was deployed in the circumflex. The procedure was completed and the patient was transferred to the holding area. The patient's heart rate began to drop and an external pacemaker was initiated and the patient was returned to the cath lab. Code procedures were initiated and the patient was intubated and pericardiocentesis was performed. The pt was taken to surgery for a cardiac window. The patient was transferred to icu on a ventilator. The patient's mental status was reported as unresponsive one day post procedure. It was further reported that, the pt was discharged three days later. The patient was taken from ambulance to home in a terminally ill condition. This was done at the family's request. The patient's mental status is unchanged. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[7834674]
The wire was disposed, therefore, no direct product analysis could be performed. Because the batch number for this complaint is unknown, the shop floor paperwork could not be examined. The root cause of this complaint could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000130-2006-00244 |
| MDR Report Key | 760829 |
| Report Source | 05,07 |
| Date Received | 2006-09-12 |
| Date of Report | 2006-08-17 |
| Date of Event | 2006-08-15 |
| Date Mfgr Received | 2006-08-17 |
| Date Added to Maude | 2006-09-18 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARK GAYLE - MS B240 |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE, MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7632250529 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PT GRAPHIX GUIDE WIRE |
| Generic Name | PTCA GUIDE WIRE |
| Product Code | DOX |
| Date Received | 2006-09-12 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 748752 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 8600 NW 41ST STREET MIAMI FL 331666202 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-12 |