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 2020-03-18 for OPTICROSS 6 HD 8669 manufactured by Boston Scientific Corporation.
[183954561]
Date of event: used the first date of the month of the aware date as no event date was provided.
Patient Sequence No: 1, Text Type: N, H10
[183954562]
It was reported that vessel perforation occurred. Two synergy stents where placed in the left anterior descending artery (lad) and circumflex artery (cx) using double kiss crush stenting technique. Post procedure, the patient was complaining of chest pain. The physician pulled out and advanced an opticross 6 hd intravascular ultrasound (ivus)to look on the cx but the ivus was kept on hitting the proximal portion of the stent. The ivus was pushed fairly hard and the opticross buckled, it prolapsed and perforated the lad leading to extreme complications. The patient was coded and the physician placed a covered stent in the lad. The patient survived and the procedure was completed with no further patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02830 |
| MDR Report Key | 9849068 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-18 |
| 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 IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTICROSS 6 HD |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-03-18 |
| Model Number | 8669 |
| Catalog Number | 8669 |
| 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 | 2020-03-18 |