MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-11 for OPTICROSS HD 8668 manufactured by Boston Scientific Corporation.
[179497939]
(b)(6). Device evaluated by mfr: a kink and detached were observed at the lap joint in the sheath assembly from the femoral marker to the proximal end. No other issues were found during the visual inspection. Impedance testing shows a wave form with presence of transmission line but very weak transduce. It was observed that the catheter leaked from the lap joint area when the catheter was flushed. During image characterization testing, a poor image appeared in the ilab system. Dimensional test was performed and is within specification. The complaint device was sent for x-ray analysis to further characterize the electrical failure. Based on the x-ray analysis, no discernible defect could be seen.
Patient Sequence No: 1, Text Type: N, H10
[179497940]
Reportable based on device analysis completed on 17jan2020. It was reported that dark image occurred. The target lesion was located in the coronary artery. A hd ivus jp opticross catheter was advanced for use. However, during preparation, dark image appeared. The procedure was completed with another of the same device. No patient involvement was reported. However, returned device analysis revealed sheath detached/separated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01327 |
| MDR Report Key | 9694352 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-02-11 |
| 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 HD |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2019-12-18 |
| Model Number | 8668 |
| Catalog Number | 8668 |
| Lot Number | 0024557159 |
| 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 | 2020-02-11 |