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 2020-02-28 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[181421988]
It was reported that catheter stuck in lesion occurred. The 75% stenosed 20mm by 3mm target lesion was located in the severely tortuous and severely calcified left circumflex coronary artery distal. An opticross vascular imaging catheter was advanced to view the target lesion. After pre-dilation by 2. 0mm balloon for treatment of lcx distal, ivus catheter was delivered, and pullback was started, but the device got stuck in the lesion midway, and it could not be removed. An additional system guidewire was passed through the lesion and ivus catheter was successfully removed. The procedure was completed with another of the same device. There were no patient complications reported and the patient is under follow up observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01781 |
| MDR Report Key | 9770479 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-09-04 |
| Date Added to Maude | 2020-02-28 |
| 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 | 2020-02-28 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| Lot Number | 0024376511 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-02-28 |