MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-01-16 for DRAGONFLY DUO IMAGING CATHETER KIT C408643 manufactured by St. Jude Medical.
[97326478]
The reported event of positioning issue and "the catheter was also found to be stretched" could not be confirmed. The results of the investigation are inconclusive since the device was not returned for analysis. Review of the device history record was not possible since the lot number was unavailable. Based on the information received, the cause of the reported incident could not be conclusively determined. The dragonfly duo instructions for use states the user should always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in device damage. To assure proper placement do not move the guide wire after the dragonfly duo imaging catheter is in place. The dragonfly duo instructions for use states that if resistance is encountered during advancement or withdrawal of the dragonfly duo imaging catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.
Patient Sequence No: 1, Text Type: N, H10
[97326479]
A dragonfly duo catheter was used to check stent apposition for a percutaneous coronary intervention (pci) procedure of a bifurcation lesion case involving the left main (lm) and proximal left anterior descending (lad) coronary arteries. Two non-abbott stents were deployed to the landing zone with overlap. While removing the catheter from the distal end, the catheter became lodged in the stent structure. The catheter was removed and an angiogram image confirmed deformation and shortening of the distal stent. The catheter was stretched at the guidewire rapid exchange (rx) notch region. Angioplasty at the stent deformation was done and a non-abbott stent was deployed to cover the deformed stent. A new dragonfly duo catheter was used to check the post-stent imaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00001 |
| MDR Report Key | 7193506 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-01-16 |
| Date of Report | 2018-01-16 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2017-12-28 |
| Date Added to Maude | 2018-01-16 |
| 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 | 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 |
| 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 | 2018-01-16 |
| Model Number | C408643 |
| Catalog Number | C408643 |
| 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 | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-16 |