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 2018-10-29 for DRAGONFLY IMAGING CATHETER 100-100-00 manufactured by St. Jude Medical Catd.
[125430780]
After successful antegrade wire crossing in the occluded artery, pre-dilation was performed several times with several balloons. Dissection was apparent in the lad part. A oct catheter was attempted to be used on a distal lesion but was unable to go through. The oct image displayed a dissection. Since blood flow was affected, stenting was performed and the oct catheter was removed. After the stent was placed a second dissection appeared. Another stent was placed for the second dissection. When a post-stent oct assessment was attempted, the oct catheter was unable to pass through the stent so a full stent assessment was not made. The patient was unstable and the procedure was stopped. Hospital policy prohibits the release of patient specific information. (b)(4), pt id (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00016 |
| MDR Report Key | 8016571 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-29 |
| Date of Report | 2018-11-14 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2018-11-13 |
| Date Added to Maude | 2018-10-29 |
| 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 | STEPHANIE O' SULLIVAN |
| 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 IMAGING CATHETER |
| Generic Name | OPTICAL COHERENCE TOMOGRAPHY, INTRAVASCULAR CATHETER |
| Product Code | ORD |
| Date Received | 2018-10-29 |
| Model Number | 100-100-00 |
| Catalog Number | 100-100-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL CATD |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-10-29 |