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 2020-03-09 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[182726899]
(b)(6). The device was returned for analysis. Visual inspection revealed the distal shaft was separated from proximal shaft at the lap joint in the sheath assembly. The imaging core was returned kinked in the detachment section. Imaging core windup began 22. 5 cm from the distal end of the connector shaft. No other visual damages were encountered upon visual inspection. Impedance testing shows an electrical open at the proximal wave form. Image characterization testing was not performed due to device condition. Dimensional test was performed and the measure was within specification.
Patient Sequence No: 1, Text Type: N, H10
[182726900]
Reportable based on device analysis completed on 18feb2020. It was reported that lost image occurred. An opticross imaging catheter was prepped for use without issue. During the procedure, the screen became black and nothing appeared. The procedure was completed with another of same device. No patient complications were reported. However, device analysis revealed a device fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02815 |
| MDR Report Key | 9808335 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-08-30 |
| Date Added to Maude | 2020-03-09 |
| 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 | 2020-03-09 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| Lot Number | 0024355250 |
| 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 | 2020-03-09 |