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 2020-03-11 for COMET 8900 manufactured by Boston Scientific Corporation.
[183118494]
It was reported that a coating issue occurred. The target lesion was located in the left anterior descending artery (lad). A comet pressure guidewire was advanced and a normal ffr was performed in the lad and the device was removed. While advancing into the right coronary artery (rca), a black damaged part was noticed to be adhered to the physicians gloves. It was noted that the black material was likely the comet coating. It was additionally noted that it was possible that the interaction with an inserter contributed to the issue, but the exact cause was unknown. The black material did not enter the patient. The procedure was completed with another of the same device. No patient complications were reported in relation to this event and the patient condition was good following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02655 |
| MDR Report Key | 9819476 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-07-21 |
| Date Added to Maude | 2020-03-11 |
| 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 | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMET |
| Generic Name | TRANSDUCER, PRESSURE, CATHETER TIP |
| Product Code | DXO |
| Date Received | 2020-03-11 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0024142561 |
| 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 | 2020-03-11 |