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 2020-03-20 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[184285267]
(b)(6). The device was returned for evaluation. Device analysis revealed that the imaging window of the device was detached. The distal housing of the transducer appears to be in good condition. Impedance testing shows a good unit wave form. Image characterization testing could not be performed due to the condition in which the device returned.
Patient Sequence No: 1, Text Type: N, H10
[184285268]
Reportable based on device analysis completed on 27feb2020. It was reported that lost image occurred. When crossing the lesion area during a percutaneous coronary intervention procedure, the screen of the opticross imaging catheter became black and nothing was displayed. The procedure was competed with another of the same device. No patient complications were reported. However, device analysis revealed a detachment of the imaging window.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03630 |
| MDR Report Key | 9860240 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-08-23 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| Lot Number | 0024317967 |
| 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 | 2020-03-20 |