MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-07-24 for DRAGONFLY DUO C408644 manufactured by St. Jude Medical.
[4959745]
While attempting to advance the dragonfly duo catheter into the proximal lad, the physician noted resistance. The guide catheter was re-positioned and several attempts were made to advance the dragonfly duo catheter. A ptca wire had buckled in the proximal lad and staining was noted. The dragonfly duo catheter was removed and a ptca balloon was inserted. A spiral dissection occurred from the proximal lad into the left main. The physician believed that either the guide catheter or the ptca wire had caused the dissection. Several stents were placed in the proximal lad and circumflex arteries, and a 6. 0x12mm ultra stent was placed in left main to tack up the vessel wall. The patient also had one stent placed in a lesion in the mid lad. The patient remained stable throughout the 3 hour procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2014-00004 |
| MDR Report Key | 4004682 |
| Report Source | 05,06,07 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-02 |
| Date of Event | 2014-07-02 |
| Date Mfgr Received | 2014-07-02 |
| Date Added to Maude | 2014-08-14 |
| 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 | DENISE JOHNSON, RN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517562000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY DUO |
| Generic Name | OCT IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2014-07-24 |
| Model Number | C408644 |
| Lot Number | 4486441 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | WESTFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-24 |