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 2020-03-05 for OPTICROSS HD 8668 manufactured by Boston Scientific Corporation.
[182388563]
It was reported that the catheter got stuck in the stent. The target lesion was located in the moderately tortuous and moderately calcified right coronary artery. An opticross hd imaging catheter was selected for use. Following pre-dilation, when removal was performed, the imaging catheter got caught inside the stent. It was tried to be retrieved using a 5. 5f non-bsc guide catheter, but only part of it was released. To make sure the stent did not get stretched, the non-bsc guide catheter was pushed in the distal. Then the proximal shaft of the imaging catheter was cut and the imaging core was then removed. A non-bsc wire was placed in the distal, but it could be pushed. Left radial 6f was tried to perform using a non-bsc double guide, but the imaging catheter could not be released. After that, the patient acted violently, so he was transported urgently to (b)(6) hospital. Another percutaneous coronary intervention was performed and during that case, the device was completely removed from the patient. The procedure was completed with another of the same device. The patient is well post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02341 |
| MDR Report Key | 9794828 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-09-13 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 8668 |
| Catalog Number | 8668 |
| Lot Number | 0024424098 |
| 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 | 2020-03-05 |