MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-24 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[180808920]
Date of event: estimated based on the aware date of 10feb2020.
Patient Sequence No: 1, Text Type: N, H10
[180808921]
It was reported via social media that vessel perforation occurred. The patient's vessels were severely calcified with lesions located in the left main trunk (lmt), left anterior descending (lad) and left circumflex (lcx) arteries. A rotablator (1. 25mm and 1. 5mm burr) was used with opticross guidance in the lad. A 2. 25 x 32mm synergy stent was uneventfully placed in the mid lad followed by a 3. 0 x 38mm synergy stent from the mid to proximal lad overlapping the previous stent. After placement of the 3. 0 x 38mm stent, the delivery system was removed and a large perforation appeared very close to the overlap region between the two stents at a bend in the lad. A covered stent was used to seal the perforation using ping-pong technique. A guidezilla was then used and supported the rotablator (1. 25mm burr) to the left main trunk/proximal lcx. A 2. 25 x 28mm synergy stent was implanted in the lcx and a 4. 0 x 12mm synergy stent was implanted in the lmt. The case was finished with an excellent result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02013 |
| MDR Report Key | 9748303 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-02-24 |
| 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 | BSC EL COYOL |
| 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 | 2020-02-24 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| 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 | 2020-02-24 |