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 2020-02-26 for COMET 8900 manufactured by Boston Scientific Corporation.
[181189371]
(b)(6). Device returned to manufacturer. The comet was returned and analysis was completed. The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities. The devices shaft showed two kinks located 176. 5cm and at the occ handle. There was some peeled coating at the 176. 5 location. The occ handle was connected to the ffr link to verify the signal strength. The signal was present as designed. The sensor port showed no residue of body fluids. The occ handle was then connected to the bench top testing equipment and the wire was inserted into the pressure chamber. 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 within 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 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.
Patient Sequence No: 1, Text Type: N, H10
[181189372]
Reportable based on analysis completed 4 feb 2020. It was reported that recognition issue occurred. It was reported that the comet pressure guidewire was not recognized. The procedure was completed with another of the same device. There were no patient complications reported. However, returned device analysis revealed peeled coating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02102 |
| MDR Report Key | 9758208 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-04-16 |
| Date Added to Maude | 2020-02-26 |
| 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 | 2020-02-26 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0023653441 |
| 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 | 2020-02-26 |