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 2011-04-22 for C7 DRAGONFLY IMAGING CATHETER 13751-05 NA manufactured by St. Jude Medical.
[2023620]
It was reported that a pt experienced a stemi three weeks prior with subsequent left anterior descending (lad) artery stent placement. The pt returned as an outpatient for a planned right coronary artery (rca) stent procedure. The physician requested oct images of the lad stent during the diagnostic angiogram. The first oct imaging run was the first angiogram taken and after completing the oct imaging run, the pt became severely hypotensive with blood pressure in the 30's to 40's. Resuscitation including fluid bolus and emergency drugs were initiated and after approx 30 mins with no charge, an intra aortic balloon pump (iabp) was inserted. A right heart catheterization revealed a wedge pressure of 5 and the physician determined dehydration of the pt made the contrast bolus intolerable. The pt required continuation of iabp and vassopressure medication. The physician anticipates the pt will make a full recovery. The physician stated that the use of the oct imaging did not cause the event and the event was unrelated to the oct dragonfly catheter. Info received on (b)(4) 2011 reported that the pt was recovered and the event was deemed a contrast reaction.
Patient Sequence No: 1, Text Type: D, B5
[9183319]
No product was returned. Review of the device history record was not possible since the lot number was unavailable. Based on the info received, the cause for the reported event could not be conclusively determined, however, the physician reported that the event was caused by a possible reaction to contrast media. The c7 dragonfly catheter's instructions for use states in the warning section - refer to the contrast media's instruction-for-use for general warnings and precautions relating to use of the contrast media.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2011-00001 |
| MDR Report Key | 2080610 |
| Report Source | 05,06,07 |
| Date Received | 2011-04-22 |
| Date of Report | 2011-04-15 |
| Date of Event | 2011-03-23 |
| Date Mfgr Received | 2011-03-23 |
| Date Added to Maude | 2011-05-12 |
| 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 | BRYAN COWELL |
| 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 | C7 DRAGONFLY IMAGING CATHETER |
| Generic Name | INTRAVASCULAR IMAGING CATHETER |
| Product Code | NQQ |
| Date Received | 2011-04-22 |
| Model Number | 13751-05 |
| 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 | 2011-04-22 |