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 2015-02-25 for DRAGONFLY DUO IMAGING CATHETER KIT C408643 manufactured by St. Jude Medical.
[13326366]
(b)(4). The dragonfly duo catheter was returned to sjm for analysis. Visual inspection identified the catheter had a presence of dried contrast. No other external visual or dimensional anomalies were noted. Optical fiber testing was performed and passed indicating the fiber was found to be intact. A liquid purge test was conducted and failed due to heavy presence of dried contrast solution. The catheter was placed in warm water to remove the residual dried contrast and the device was then able to be flushed. Evaluation of the purge port was conducted and it was identified to have a clean, unobstructed pathway after soaking. The catheter lumen was microscopically inspected and no anomalies were noted. The catheter lumen was found to be intact and without issue. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The review determined the process was performed and completed in accordance with sjm specifications and procedures. If adequate clearing is not obtained the oct imaging system will not initiate an automatic pullback. The cause of the reported clearing difficulty is unknown.
Patient Sequence No: 1, Text Type: N, H10
[18031673]
The dragonfly duo catheter was placed in the lad vessel. The catheter was flushed with contrast but no contrast could be seen in live view. The guiding catheter was not initially placed well in the ostium; therefore, it was placed deeper and another pullback was initialized but the contrast could not be seen again on live view. After about 2-3 seconds the patient experienced ventricular fibrillation. The patient became instable and a defibrillator was used. The procedure was aborted after the patient was stable for 10 minutes. After five hours of being monitored in the hospital the patient was still stable and had no further issues.
Patient Sequence No: 1, Text Type: D, B5
[18393141]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004672267-2015-00001 |
| MDR Report Key | 4546353 |
| Report Source | 01,05,07 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-02-05 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-02-05 |
| Device Manufacturer Date | 2014-05-31 |
| Date Added to Maude | 2015-02-25 |
| 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 |
| 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, INC. |
| 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 DUO IMAGING CATHETER KIT |
| Generic Name | INTRAVASCULAR IMAGING CATHETER |
| Product Code | ORD |
| Date Received | 2015-02-25 |
| Returned To Mfg | 2015-04-06 |
| Model Number | C408643 |
| Catalog Number | C408643 |
| Lot Number | 4606723 |
| Device Expiration Date | 2016-05-31 |
| Operator | PHYSICIAN |
| 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 | 2015-02-25 |