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 2020-03-02 for COMET 8900 manufactured by Boston Scientific Corporation.
[181638237]
Device evaluated by mfr: returned product consisted of an ffr comet pressure wire connected to the occ cable. The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities. The shaft showed 3 kinks located at 38cm, 112cm and 178. 5cm from the tip. There was peeled coating at the 178cm location. The tip showed a bend. The occ handle was connected to the ffr link for signal verification. The signal was present as designed. The occ handle cap was loosened to remove the wire. There was no issue with removing the wire. The sensor housing showed no residue of body fluids. The wire was inserted into the pressure chamber test equipment and the pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases. The pressure sensor functioned as designed. The coefficient was confirmed to be in specification. The occ handle was again connected to the ffr link. The device was then connected to the polaris (ilab) test equipment via bluetooth signal. The wire communicated to the polaris system and zeroed as designed. The wire was inserted into the test pressure chamber and the wire transferred a pd pressure waveform to the polaris which indicates a functioning wire. The wire was removed from the occ handle with no issues. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Patient Sequence No: 1, Text Type: N, H10
[181638238]
Reportable based on analysis completed on 07feb2020 it was reported that a pressure guidewire was unable to zero. The target lesion was located in the left anterior descending artery (lad). A comet pressure guidewire was advanced to the target lesion, but was unable to zero. This occurred while attempting to equalize. It was noted that the pressure guidewire was initially zeroed outside of the patient, but would not equalize. The procedure was completed without using the device or exchanging the device. No patient complications were reported in relation to this event and the patient was reported to be fine. However, device analysis revealed peeled coating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01969 |
| MDR Report Key | 9775918 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-09-09 |
| Date Added to Maude | 2020-03-02 |
| 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 | 2020-03-02 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0024398968 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-02 |