MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-09-28 for DRAGONFLY DUO IMAGING CATHETER KIT C408643 manufactured by St. Jude Medical Catd.
[26885909]
A dragonfly duo imaging catheter was used post-stenting near a bifurcation. When the dragonfly duo imaging catheter was removed, resistance was felt. Additional force was used to fully remove the dragonfly duo imaging catheter. A post-procedure angiogram was performed and it was noted that the stent had become folded and a dissection was present. Another stent was used over the folded stent and the procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
[35833096]
(b)(4). Product evaluation: the device history record was reviewed and the returned product was evaluated. The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record. The device evaluation revealed the catheter fiber was intact. A 0. 014 guide wire was inserted through the distal end of the catheter and out the guidewire exit port with no issues. The tip was examined under microscopic evaluation and no anomalies were noted. The guidewire exit port was found to be a slight deformation indicative of force placed upon it. The window portion of the catheter was found to be within specification. The catheter rfid indicated that the catheter had not completed any pullbacks for the catheter load and pullback counts were zero which does not align with the event description. A partial cine of the case was provided which provided limited information. An oct video was provided showing a pullback performed with the dragonfly catheter illustrating the presence of a stent well positioned within the vessel and not malapposed. The catheter evaluation concluded that the catheter was within specification except for the guidewire exit port condition due to handling. Based on the event description and the catheter evaluation the cause of the reported event is inconclusive. The dragonfly duo ifu states that the user should observe all advancement and movement of the dragonfly duo imaging catheter under fluoroscopy and always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To assure proper placement do not move the guide wire after the dragonfly duo imaging catheter is in place. The dragonfly duo ifu 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
| Report Number | 3009600098-2015-00001 |
| MDR Report Key | 5107694 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-09-28 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-09-02 |
| Date Mfgr Received | 2015-09-02 |
| Device Manufacturer Date | 2013-10-31 |
| Date Added to Maude | 2015-09-28 |
| 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 CATD |
| 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 | 2015-09-28 |
| Returned To Mfg | 2015-09-21 |
| Model Number | C408643 |
| Catalog Number | C408643 |
| Lot Number | 4272870 |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL CATD |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-28 |