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 2012-03-27 for DRAGONFLY IMAGING CATHETER 13751-02 NA manufactured by St Jude Medical.
[2596692]
In preparation for a case with oct imaging of a stent in the mid lad, a dissection of the very short left-main was caused by the guiding catheter. This was not apparent until after oct imaging. Very poor blood clearance was obtained such that the physician assumed that the guiding catheter had slipped out prior to the pullback. After the pullback, the pt went into ventricular fibrillation and a large dissection extending along the lad and possibly back to the aorta. Pt was stabilized and left-main and lad were successfully treated with a new proximal stent. Physician stated that absolutely there was no suggestion that the imaging catheter caused this incident and he had a similar experience recently (in a non oct imaging case).
Patient Sequence No: 1, Text Type: D, B5
[9705884]
Based on the info provided incident was not caused by the dragonfly imaging catheter used for oct imaging. No product was returned. Review of the device history record was not possible since the lot number was unavailable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2012-00002 |
| MDR Report Key | 2508840 |
| Report Source | 05,06,07 |
| Date Received | 2012-03-27 |
| Date of Report | 2012-03-22 |
| Date of Event | 2012-02-29 |
| Date Mfgr Received | 2012-02-29 |
| Date Added to Maude | 2012-03-29 |
| 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 | ANN GRAVES |
| Manufacturer Street | ONE TECHNOLOGY PARK DRIVE |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer Phone | 9786921408 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY IMAGING CATHETER |
| Generic Name | INTERVASCULAR IMAGING CATHETER |
| Product Code | NQQ |
| Date Received | 2012-03-27 |
| Model Number | 13751-02 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention | 2012-03-27 |