MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-11 for DRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER C408646 manufactured by St. Jude Medical.
[105237381]
A dragonfly optis catheter was used for pci on three diseased vessels - lcx, lad, and rca lesions. The lesion in the lcx was successfully treated. The proximal lad had no tortuosity, calcification, or stenosis. The patient experienced ventricular fibrillation when the catheter was inserted into the proximal lad lesion and contrast was used. Electrical defibrillation was done and the patient stabilized. Another oct attempt was performed and when the contrast was used, the patient experienced ventricular fibrillation again. Electrical defibrillation was used again and the patient stabilized. A non-abbott device was used to complete the treatment. The rca was rescheduled to be treated two days later as elective staged pci and was successfully treated with non-abbott devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00007 |
| MDR Report Key | 7422984 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-11 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-03-28 |
| Date Mfgr Received | 2018-04-02 |
| Device Manufacturer Date | 2017-11-16 |
| Date Added to Maude | 2018-04-11 |
| 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 | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 4 ROBBINS DRIVE |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01886 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER |
| Generic Name | DF OPTIS KIT OUS |
| Product Code | ORD |
| Date Received | 2018-04-11 |
| Returned To Mfg | 2018-04-19 |
| Model Number | C408646 |
| Catalog Number | C408646 |
| Lot Number | 6206691 |
| ID Number | 00183739000654 |
| Device Expiration Date | 2019-11-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-04-11 |