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 2020-02-07 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical Catd.
[188860747]
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.
Patient Sequence No: 1, Text Type: N, H10
[188860748]
During a percutaneous coronary intervention procedure, a perforation occurred when using the catheter in a lad#6 lesion with vessel tortuosity and moderate stenosis. A rotablator was used and then the catheter was advanced. The catheter was difficult to advance and became kinked when advancing the device into the lesion. A perforation was noted around lad#5 on the cine image and an occlusion occurred. Two graftmasters were used and the procedure moved on to two vessel coronary artery bypass surgery. The patient was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2020-00002 |
| MDR Report Key | 9683937 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-07 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2020-02-07 |
| 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 | 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 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? OPTIS? CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-02-07 |
| Model Number | C408641 |
| Lot Number | 7106195 |
| 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 CATD |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-07 |