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 2018-02-12 for DRAGONFLY C408645 manufactured by St. Jude Medical.
[99878122]
A dragonfly catheter was attempted to be used in a heavily calcified proximal lad lesion. A previously placed stent had recoiled and needed to be opened. The vessel was wired and the catheter was directed through but got stuck in the stent. The distal marker broke off and remained inside the vessel. The physician does not remember the specific details but managed to remove everything that broke off. Then, the stent was pre-dilated and another dragonfly catheter was used to complete the procedure. There were no adverse patient effects. There was a slight delay in the procedure but was not clinically significant.
Patient Sequence No: 1, Text Type: D, B5
[113569931]
An event of "the distal marker broke off and remained inside the vessel" was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. The dragonfly optis instructions for use states the user should always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To assure proper placement do not move the guide wire after the dragonfly optis imaging catheter is in place. The dragonfly optis instructions for use states that if resistance is encountered during advancement or withdrawal of the dragonfly optis imaging catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient. The dragonfly optis instructions for use states the user should observe all advancement and movement of the dragonfly optis imaging catheter under fluoroscopy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009600098-2018-00005 |
| MDR Report Key | 7265409 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-12 |
| Date of Report | 2018-03-02 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-02-12 |
| 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 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 | DFII STANDALONE OUS |
| Product Code | ORD |
| Date Received | 2018-02-12 |
| Model Number | C408645 |
| Catalog Number | C408645 |
| 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 | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-12 |