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 2018-01-04 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical.
[96337343]
The dragonfly optis catheter was used in an rca lesion with mild stenosis. The initial pullback was performed normally. When the catheter was advanced to the lesion again for another pullback in post-pci, the dragonfly became stuck in the stent strut. The catheter could be removed from the patient by moving forward and backward repeatedly. Poba with dcb was performed in the stent again, and another dragonfly optis catheter was used for oct imaging. By imaging, it was found that the shape of the stent was partly changed, but since sufficient dilatation was achieved, the procedure was completed. Patient specific information of patient identifier, age or birthdate, gender, and weight are not available for this complaint.
Patient Sequence No: 1, Text Type: D, B5
[110666544]
The reported event of positioning issue was confirmed; however, the reported event of "the surface between the distal tip and the guidewire exit port of the catheter became rough" could not be confirmed. The results of the investigation concluded that the distal edge of the guidewire exit port had been stretched. No visual anomalies were noted on the surface of the catheter between the distal tip and the guidewire exit port. The surface of the catheter between the distal tip and the guidewire exit port felt smooth to the touch. Functional testing revealed a 0. 014? Guidewire was able to be inserted through the tip of the catheter and out the guidewire exit port with no anomalies. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the reported positioning issue is consistent with the stretched distal edge of the guidewire exit port. The cause of the "the surface between the distal tip and the guidewire exit port of the catheter became rough" remains unknown. The dragonfly optis 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 optis imaging catheter is in place. The dragonfly optis instructions for use states that if resistance is encountered during advancement or withdrawal of the dragonfly optis 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
[110666545]
It was reported that the surface between the distal tip and the guidewire exit port of the dragonfly optis catheter became rough. It was also reported that the stent appeared partly fractured when observed with the replacement dragonfly optis catheter, but sufficient dilatation was achieved so the procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00002 |
| MDR Report Key | 7163367 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-24 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2018-01-10 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2018-01-04 |
| 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? OPTIS? CATHETER |
| Generic Name | DFII KITBOX OUS |
| Product Code | ORD |
| Date Received | 2018-01-04 |
| Returned To Mfg | 2018-01-10 |
| Model Number | C408641 |
| Catalog Number | C408641 |
| Lot Number | 6096344 |
| ID Number | 00183739000951 |
| Device Expiration Date | 2019-08-28 |
| 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 |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-04 |