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 2018-04-13 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical.
[105390175]
The first dragonfly optis catheter was purged with contrast using a syringe before connecting the device to the doc, there was less resistance felt compared to usual, and the contrast flowed out from the tip of the device too smoothly. After crossing the device into the lad lesion and when the device was purged with the syringe before a pullback, air bubbles came out from the device catheter. The air bubble was confirmed on angiogram; and flowed through the coronary artery. It appeared to be the diameter of the coronary vessel (3mm). The patient experienced ischemic symptoms, st elevation was observed on an electrocardiogram and experienced chest pain. After ten minutes the air bubble disappeared and the patient's symptoms were resolved. They stopped using the device and a second dragonfly optis catheter was purged before connecting to the doc, but there was less resistance felt with this device also. A non-abbott device was used instead to continue and complete the procedure. No additional information is expected. Patient specific information of patient identifier, age or birthdate, gender, and weight are not available for this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00008 |
| MDR Report Key | 7428574 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-13 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2017-12-12 |
| Date Added to Maude | 2018-04-13 |
| 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? CATHETER |
| Generic Name | DFII KITBOX OUS (NO SYRINGE) |
| Product Code | ORD |
| Date Received | 2018-04-13 |
| Model Number | C408641 |
| Catalog Number | C408641 |
| Lot Number | 6207022 |
| ID Number | 00183739000951 |
| Device Expiration Date | 2019-12-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Other | 2018-04-13 |