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 2017-07-20 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical.
[80620199]
The results of the investigation are inconclusive since the device was not returned for analysis. Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures. 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 observe all advancement and movement of the dragonfly optis imaging catheter under fluoroscopy. 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.
Patient Sequence No: 1, Text Type: N, H10
[80620200]
After stenting was performed, the dragonfly optis catheter got stuck in the stent strut. A balloon was used to withdraw the catheter. After that, the catheter was attempted to cross into the lesion again, but the in vivo image was lost. A non-sjm device was used to complete the procedure. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2017-00003 |
| MDR Report Key | 6730126 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-20 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-09-05 |
| Device Manufacturer Date | 2016-11-30 |
| Date Added to Maude | 2017-07-20 |
| 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 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 | 2017-07-20 |
| Returned To Mfg | 2017-08-10 |
| Model Number | C408641 |
| Catalog Number | C408641 |
| Lot Number | 5717635 |
| ID Number | 00183739000951 |
| Device Expiration Date | 2018-11-30 |
| 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. Required No Informationntervention | 2017-07-20 |