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 2012-06-25 for DRAGONFLY IMAGING CATHETER 13751-02 NA manufactured by St. Jude Medical.
[2726223]
The imaging vessel was stented and then oct imaging was attempted for stent assessment. During catheter insertion some resistance was felt and it did not feel like a typical smooth delivery. Physician noticed the catheter buckled proximal to the second marker band where a dissection was seen. Dissection was stented and patient is fine. Physician is a routine oct user and the cause of the dissection is unclear. The physician stated that the event may have been caused by the catheter.
Patient Sequence No: 1, Text Type: D, B5
[10061791]
The device history record was reviewed and the device was manufacturing in accordance to sjm specification. A request has been placed to the hospital for images and the device and upon receipt further investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2012-00004 |
| MDR Report Key | 2632374 |
| Report Source | 05,06,07 |
| Date Received | 2012-06-25 |
| Date of Report | 2012-06-22 |
| Date of Event | 2012-05-30 |
| Date Mfgr Received | 2012-05-30 |
| Device Manufacturer Date | 2012-02-28 |
| Date Added to Maude | 2012-06-29 |
| 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 | DRAGONFLY IMAGING CATHETER |
| Generic Name | INTERVASCULAR IMAGING CATHETER |
| Product Code | NKK |
| Date Received | 2012-06-25 |
| Model Number | 13751-02 |
| Catalog Number | NA |
| Lot Number | DF-12-026 |
| Device Expiration Date | 2014-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2012-06-25 |