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 2013-03-19 for DRAGONFLY IMAGING CATHETER 13751-05 NA manufactured by St. Jude Medical.
[3316066]
The dragonfly imaging catheter was used to evaluate the placement of a stent. Upon removal of the dragonfly imaging catheter, the physician stated that the dragonfly imaging catheter got caught in the stent. The physician stated he used the guidewire to dislodge the dragonfly imaging catheter. The guidewire became prolapse and got stuck in the stent. The guidewire was removed but the stent was damaged. Due to a moderate flow disturbance the physician placed another stent in the patient. Flow improved and the patient was stable.
Patient Sequence No: 1, Text Type: D, B5
[10651342]
The device will not be returned and the lot number of the device is unavailable. Images have been requested from the facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2013-00001 |
| MDR Report Key | 3016714 |
| Report Source | 05,06,07 |
| Date Received | 2013-03-19 |
| Date of Report | 2013-02-20 |
| Date of Event | 2013-02-18 |
| Date Mfgr Received | 2013-02-20 |
| Date Added to Maude | 2013-03-25 |
| 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 | 2013-03-19 |
| Model Number | 13751-05 |
| Catalog Number | NA |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2013-03-19 |