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 2020-03-12 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[183177269]
Device evaluated by mfr. : the device was returned for analysis. Visual inspection revealed that a kink was observed in the imaging core. The imaging window was detached from the sheath assembly. The distal housing of the transducer appears to be in good condition. The imaging core was fully retracted and fully advanced. Impedance testing shows a good unit wave form. Ilab testing could not be performed due to the detachment of the imaging window. No other issues or defects were observed during product analysis of the returned device.
Patient Sequence No: 1, Text Type: N, H10
[183177270]
Reportable based on device analysis completed on 21feb2020. It was reported that lost image occurred. A percutaneous coronary intervention was being performed. The 95% stenosed target lesion was located in the severely calcified left anterior descending with 50 mm in length and 3. 0 mm vessel diameter. An opticross imaging catheter was selected for use. During a percutaneous coronary intervention, it was noted that the catheter could not show the image. The procedure was completed with another of the same device. No patient complications were reported. However, device analysis noted that the imaging window was detached from the sheath assembly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03125 |
| MDR Report Key | 9825361 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-06-21 |
| Date Added to Maude | 2020-03-12 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTICROSS |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| Lot Number | 0023992634 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |