MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-04-03 for DRAGONFLY 13751-02 manufactured by St. Jude Medical.
[3205924]
During an oct imaging procedure, the physician advanced the unspecified guide wire and dragonfly catheter through a 50% restenosed stent located in the non-tortuous inter-ventricular artery (va). The physician had difficulty placing the dragonfly catheter through the imaging region. After the dragonfly catheter was positioned, contrast was injected. Due to poor blood clearing, the physician had difficulties visualizing the restenosed stent and surrounding vessel tomography. The pt experienced pain and the physician noted via electrocardiogram and an unspecified 'biological test' that a thrombus occurred. The thrombus was located and removed from the pt. The pt was transferred to intensive care post-procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004672267-2013-00002 |
| MDR Report Key | 3042068 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-04-03 |
| Date of Report | 2013-03-06 |
| Date of Event | 2013-03-05 |
| Date Mfgr Received | 2013-03-06 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-04-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DENISE JOHNSON |
| Manufacturer Street | 4 ROBBINS RD |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer Phone | 6517562000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY |
| Generic Name | INTRAVASCULAR IMAGING CATHETER |
| Product Code | NQQ |
| Date Received | 2013-04-03 |
| Model Number | 13751-02 |
| Lot Number | DF-12-865 |
| 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 | 2013-04-03 |