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 2012-09-19 for DRAGONFLY IMAGING CATHETER 13751-02 NA manufactured by St. Jude Medical.
[2893363]
Physician did two oct pullbacks on the lad vessel of the patient. Right after the second run, patient suffered ventricular fibrillation. Cpr was administered and patient was resuscitated, with no further event. The physician alleged that the flushing of contrast medium during the pullback caused the event, as the vessel was deprived of blood for a brief period of time and thus became ischaemic.
Patient Sequence No: 1, Text Type: D, B5
[10203571]
No product was returned. The device history record was reviewed and the device was manufactured in accordance to sjm specifications. Based on the information received, the cause of the reported event could not be conclusively determined; however, the physician stated that the contrast flushing caused the fibrillation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2012-00006 |
| MDR Report Key | 2756297 |
| Report Source | 05,06,07 |
| Date Received | 2012-09-19 |
| Date of Report | 2012-09-17 |
| Date of Event | 2012-08-24 |
| Date Mfgr Received | 2012-08-24 |
| Device Manufacturer Date | 2011-11-30 |
| Date Added to Maude | 2012-09-25 |
| 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 | NKK |
| Date Received | 2012-09-19 |
| Model Number | 13751-02 |
| Catalog Number | NA |
| Lot Number | DF-11-771 |
| Device Expiration Date | 2013-11-30 |
| 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 | 2012-09-19 |