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 2018-03-28 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical Catd.
[103779231]
The reported event of? The device could not be withdrawn? Was confirmed. The results of the investigation concluded that the guidewire exit port had been stretched in an outward direction toward the distal end. 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. Although the exact cause of the reported event remains unknown, the guidewire exit port damage is consistent with the reported withdrawal difficulties. The cause of the guidewire exit port damage is consistent with damage during use. The dragonfly optis instructions for use states appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed. 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
[103779232]
The dragonfly optis catheter was used in lad#7 with 90% stenosis and severe vessel calcification. Pullbacks were performed two times in pre-pci and one time in post-pci normally. Stenting was performed and a stent balloon was used three times, but the severely-calcified lesion located at the center of the stent was not fully dilated. Post-dilatation was performed four more times with a balloon. After that, another pullback was performed, but it was found out that the center of the stent was still not dilated sufficiently. When the device was attempted to withdraw in order to perform another dilatation, the device got caught on something. Torque was applied and pushing and pulling attempts were made but the device could not be withdrawn. It was thought that it was the gw exit port that was stuck and a micro-catheter was advanced from the guidewire up to the exit port and then pulled out, but the dragonfly still did not move at all. Then a guidewire was advanced and a balloon was dilated near the exit port. The situation did not change with the first dilatation. When a larger sized balloon was dilated, movement of the device was confirmed on the angiogram. The dragonfly optis catheter was retrieved successfully by pulling the device out slowly. No fracture occurred on the device. The procedure was completed without using another dragonfly catheter. No consequences occurred on the patient. No additional information is expected. 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
| Report Number | 3009600098-2018-00006 |
| MDR Report Key | 7379350 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-03-09 |
| Device Manufacturer Date | 2017-11-16 |
| Date Added to Maude | 2018-03-28 |
| 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? OPTIS? CATHETER |
| Generic Name | DFII KITBOX OUS (NO SYRINGE) |
| Product Code | ORD |
| Date Received | 2018-03-28 |
| Returned To Mfg | 2018-03-21 |
| Model Number | C408641 |
| Catalog Number | C408641 |
| Lot Number | 6206667 |
| ID Number | 00183739000951 |
| Device Expiration Date | 2019-11-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-03-28 |