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 2020-02-05 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[178388761]
The device was returned for analysis. Kinks were observed in the sheath assembly from femoral marker to the distal end. Kinks were observed at the lapjoint in the sheath assembly from femoral marker to the distal end. It was observed that the imaging window was found detached from the lapjoint. Windup was encountered in the non-heat shrink area of the telescope. Ic windup began 23. 60 cm from the distal end of the connector shaft. Impedance testing shows an electrical open at the proximal wave form. During image characterization testing, no image appeared in the ilab system. The flushing process cannot be preformed due to the condition of the device. The od measure of the lapjoint was within specification. Microscope inspection revealed the windup in the keyence.
Patient Sequence No: 1, Text Type: N, H10
[178388762]
Reportable based on device analysis completed on 09jan2020. It was reported that lost image occured. The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery. An opticross imaging catheter was advanced to view the target lesion and the image was lost during pullback. The procedure was completed with a same device. No patient complications were reported however, returned device analysis revealed that the imaging window was detached from the lapjoint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01036 |
| MDR Report Key | 9674124 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-07-22 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| Returned To Mfg | 2019-12-13 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| Lot Number | 0024145979 |
| 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 | 2020-02-05 |