MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-27 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[181426404]
Age at time of event: 18 years or below. Weight: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[181426405]
It was reported that device interaction and removal difficulty occurred. The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified distal right coronary artery to atrioventricular branch and mid right coronary artery (rca). A w-perm sled ster bag opticross was introduced for an intravascular ultrasound (ivus) check. After predilatation was performed in the lesions using an nc emerge 2. 25x12, a 2. 25x16mm synergy ii drug-eluting stent was placed in the rca distal to the atrioventricular branch. During ivus, stent malposition was confirmed and post-dilatation was performed again using nc emerge 2. 25x12. Another ivus check was performed and stent apposition remained. When an attempt was made to remove the opticross, the guidewire exit port caught in the strut near the distal edge of the placed stent and the opticross could not be removed. The physician did not notice much resistance when pulling the opticross, but the guide catheter was deeply engaged in the coronary artery. At that time, the stent moved/migrated around the proximal part of the distal rca and fluoroscopy confirmed the stent length had been shortened. After cutting the outer part of the opticross proximal shaft, the imaging core was pulled and a 0. 025 inch wire was inserted. The opticross was again pulled but could not be removed. A non-bsc guidewire was passed through the stent area by double guide. A microcatheter, a non-bsc ivus catheter, and a 1. 00x12 mm balloon were all inserted but none were able to pass the stent part. Another microcatheter was placed in the opticross and was able to forcibly remove the device. Another attempt was made to expand the synergy stent with a 2. 00x12mm balloon, but it could not pass through the stent. When fluoroscopy was performed, no problem with blood flow was noted so post dilatation of the synergy stent was stopped. The procedure was completed by placing a 3. 00x12mm non-bsc stent in the mid rca. No patient complications were reported. Three days later percutaneous coronary intervention was completed on the left circumflex artery without issue and the patient condition was good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02121 |
| MDR Report Key | 9764423 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-02-27 |
| 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 | 2020-02-27 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| Lot Number | 0024554374 |
| 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 | 2020-02-27 |