MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-20 for DRAGONFLY manufactured by St. Jude Medical.
[114625234]
The dragonfly optis catheter got stuck on something in the body. The device came off the wire, and the catheter itself did not come back out; it remained in the body after the wire was removed. A balloon dilation catheter was inflated to manipulate the device out of the body. Once removed from the body, the dragonfly optis catheter piece left behind was noted to be in one piece. The procedure ended without any further intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00015 |
| MDR Report Key | 7707928 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-20 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-06-27 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-07-20 |
| 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 Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL CATD |
| 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 |
| Generic Name | INTRAVASCULAR IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2018-07-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2018-07-20 |