MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-08-04 for DRAGONFLY 13751-02 manufactured by St Jude Medical Catd.
[4800937]
A dragonfly catheter was used and the minimum lumen area measurement was mis-interpreted as the minimum lumen diameter; therefore, the stent was oversized. A dissection occurred and a second stent was successfully placed to cover the dissection. The patient was reported to be stable after the procedure.
Patient Sequence No: 1, Text Type: D, B5
[12180057]
The device was not returned for analysis, limiting the investigation to the review of the device history record. Review identified that each mfg and inspection operation was performed and completed in accordance with sjm specifications and procedures prior to release from sjm. Based on the info received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009600098-2014-00005 |
| MDR Report Key | 4033967 |
| Report Source | 01,05,07 |
| Date Received | 2014-08-04 |
| Date of Report | 2014-07-11 |
| Date of Event | 2014-07-09 |
| Date Mfgr Received | 2014-07-11 |
| Device Manufacturer Date | 2013-10-31 |
| Date Added to Maude | 2014-08-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE JOHNSON, RN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY |
| Generic Name | OCT IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2014-08-04 |
| Model Number | 13751-02 |
| Catalog Number | 13751-02 |
| Lot Number | 4227829 |
| Device Expiration Date | 2015-10-31 |
| 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 | WESTFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-04 |