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 2018-05-07 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical.
[107561482]
The dragonfly optis catheter was used for a follow-up case of a placed stent (des). Before oct imaging, ffr measurement was performed with a pressurewire x, wireless. After that, using the pressurewire x, wireless as a guidewire, the catheter was attempted to cross into the lesion but it could not be passed through. Therefore, another, non-abbott, guidewire was also inserted. The catheter could be crossed into the lesion and used for oct imaging. After that, the catheter got stuck while withdrawing from the patient. It was suspected that the catheter got caught with the placed stent, so poba with a balloon was performed inside the stent, which allowed the removal of the catheter from the patient. The distal part of the catheter was found stretched. 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 | 3009600098-2018-00009 |
| MDR Report Key | 7493271 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-04-12 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2018-01-11 |
| Date Added to Maude | 2018-05-07 |
| 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 | 2018-05-07 |
| Returned To Mfg | 2018-04-30 |
| Model Number | C408641 |
| Catalog Number | C408641 |
| Lot Number | 6266435 |
| ID Number | 00183739000951 |
| 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 | 2018-05-07 |