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 2020-02-13 for OPTICROSS HD 8668 manufactured by Boston Scientific Corporation.
[179263969]
It was reported that catheter stuck occurred. The 90% stenosed, 40mm in length x 3. 5mm in diameter target lesion was located in the moderately tortuous and moderately calcified mid proximal left anterior descending (lad) artery. After implanting overlapping non bsc stents, an opticross hd imaging catheter was advanced for use but got stuck. It could not be determined whether it got stuck within a previously placed stent. The opticross was able to be retrieved by performing plain old balloon angioplasty (poba) using nc balloon. It was noted there was no stent malposition observed with previously placed stent. The procedure was completed with the original device used. No complication were reported and the patients condition was reported as good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01486 |
| MDR Report Key | 9705929 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-02-13 |
| 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 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 | 2020-02-13 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 8668 |
| Catalog Number | 8668 |
| Lot Number | 0024600042 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-02-13 |