MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-05 for COMET 8900 manufactured by Boston Scientific Corporation.
[177855760]
It was reported that a tip detachment occurred. A functional flow reserved (ffr) procedure was being performed. The target lesion was located in the tortuous and non calcified obtuse marginal (om) off of the circumfix. There were no previous devices inside of the om. This 185cm comet pressure guidewire was advanced to the lesion, they started performing ffr measurements, but they were unable to get a pressure reading. Fluoroscopy was used to see what may have been causing the issue, at this time the physician noticed that the radiopaque tip had separated from the body of the guidewire. They tried to pullback on the guidewire hoping that there was a small thread still connecting the two pieces, but they had completely separated. They proceeded to use wires and balloons to pull the guidewire tip back and ultimately, they needed to use a snare to remove the detached tip. The detached guidewire tip was retrieved and the procedure was completed with a different device. There were no adverse events to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00861 |
| MDR Report Key | 9672487 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-09-30 |
| Date Added to Maude | 2020-02-05 |
| 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 | 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 | 2020-02-05 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0024517148 |
| 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 | 2020-02-05 |