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 2013-12-20 for DRAGONFLY DUO KIT C408643 manufactured by St Jude Medical.
[20861951]
During the oct imaging procedure of the proximal left anterior descending artery (post balloon dilation), the physician injected 20ml of a 70% contrast/ 30% saline mix. The physician was not satisfied with the image and performed a second pullback which was still unsatisfactory. The physician then decided to inject pure contrast for the 3rd pullback. The patient went into ventricular tachycardia (vt) after 8ml of contrast was injected. Cpr and an aed were used to treat the patient's vt and restore a normal rhythm. They did not finish the oct imaging procedure. The patient survived.
Patient Sequence No: 1, Text Type: D, B5
[21144428]
The device was not returned for analysis, limiting the investigation to the review of the device history record. Review identified that each manufacturing and inspection operation was performed and completed in accordance with sjm specifications and procures prior to release from sjm. Based on the information received, the cause of the reported event remains unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009600098-2013-00002 |
| MDR Report Key | 3551106 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-09 |
| Date of Event | 2003-12-04 |
| Date Mfgr Received | 2013-12-09 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-01-06 |
| 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 | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 554420000 |
| Manufacturer Country | US |
| Manufacturer Postal | 554420000 |
| Manufacturer Phone | 6517562000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY DUO KIT |
| Generic Name | INTRAVASCULAR IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2013-12-20 |
| Model Number | C408643 |
| Lot Number | 4079588 |
| ID Number | NA |
| Device Expiration Date | 2015-09-30 |
| 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. Required No Informationntervention | 2013-12-20 |