MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-03-16 for C7 DRAGONFLY IMAGING CATHETER 13751-02 NA manufactured by St Jude Medical.
[16725363]
The fiber became blocked at the junction of two stents that had just been deployed in a pt with a heavily calcified artery. Angiographic images showed the blockage was in a mesh stent, at the proximal portion of the monorail section of the fiber. Surgery was performed to remove the fiber and the pt was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
[16999814]
The results of our investigation are inconclusive since no device was returned to sjm for analysis. A review of the device history record confirmed all mfg processes were completed and the device was mfg in accordance with sjm specifications. The cause of the fiber being caught at the junctin of the two stents remains unk; however, info indicated the stent became stuck during the second pullback and the stent struts were not flushed in the calcified artery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2012-00001 |
| MDR Report Key | 2499487 |
| Report Source | 05,06,07 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-03-06 |
| Date of Event | 2012-02-17 |
| Date Mfgr Received | 2012-02-17 |
| Device Manufacturer Date | 2011-10-31 |
| Date Added to Maude | 2012-03-23 |
| 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 | ANN GRAVES |
| Manufacturer Street | ONE TECHNOLOGY PARK DRIVE |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer Phone | 9786921408 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C7 DRAGONFLY IMAGING CATHETER |
| Generic Name | INTRAVASCULAR IMAGING CATHETER |
| Product Code | NQQ |
| Date Received | 2012-03-16 |
| Model Number | 13751-02 |
| Catalog Number | NA |
| Lot Number | DF-11-709 |
| ID Number | NA |
| Device Expiration Date | 2013-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST JUDE MEDICAL |
| Manufacturer Address | WESTFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-03-16 |