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 2017-08-17 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical.
[82881358]
The results of the investigation concluded that a distal edge of the guidewire exit port had been stretched. Functional testing revealed that 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 met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record. The cause of the stretched guidewire exit port's distal edge is consistent with damage during use. The cause of the reported event remains unknown. Observe all advancement and movement of the dragonfly optis imaging catheter under fluoroscopy. 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 optis imaging catheter is in place. 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
[82881359]
A pullback was successfully performed in a tortuous lesion and pci was performed. After pci, the catheter was advanced to the lesion with resistance felt. When the catheter was attempted to be removed from the patient, it was stuck to the guidewire. The catheter and guidewire were removed together from the patient and the procedure was completed with another dragonfly optis catheter. During the procedure, the patient's blood pressure dropped and the patient experienced chest discomfort. The patient recovered without intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2017-00004 |
| MDR Report Key | 6799998 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-07-19 |
| Device Manufacturer Date | 2017-04-04 |
| Date Added to Maude | 2017-08-17 |
| 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 (NO SYRINGE) |
| Product Code | ORD |
| Date Received | 2017-08-17 |
| Returned To Mfg | 2017-07-28 |
| Model Number | C408641 |
| Catalog Number | C408641 |
| Lot Number | 5906095 |
| ID Number | 00183739000951 |
| Device Expiration Date | 2019-04-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Other | 2017-08-17 |