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 2012-08-07 for DRAGONFLY IMAGING CATHETER 13751-02 NA manufactured by St. Jude Medical.
[15150318]
An oct procedure of the left circumflex artery was being performed and the dragonfly catheter was not able to cross a circumflex lesion. After pulling the dragonfly catheter back into the guide (ebu 3. 75), a cine was performed and a dissection of the left main artery was observed. The patient was on medications of 75 mg plavix and angiomax during the procedure. The patient was transferred to the ccu and treated with no further complications.
Patient Sequence No: 1, Text Type: D, B5
[15277693]
The device history record was reviewed and the device was manufactured in accordance to sjm specifications. A request has been placed to the hospital for images and the device and upon receipt, further investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2012-00005 |
| MDR Report Key | 2688249 |
| Report Source | 05,06,07 |
| Date Received | 2012-08-07 |
| Date of Report | 2012-08-03 |
| Date of Event | 2012-07-10 |
| Date Mfgr Received | 2012-07-09 |
| Device Manufacturer Date | 2012-06-30 |
| Date Added to Maude | 2012-08-10 |
| 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 | NKK |
| Date Received | 2012-08-07 |
| Model Number | 13751-02 |
| Catalog Number | NA |
| Lot Number | DF-12-545 |
| Device Expiration Date | 2014-06-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-08-07 |