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.
[177856870]
Returned product consisted of an ffr comet pressure wire connected to the occ handle. The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities. The devices shaft showed one kink located 126. 5cm from the tip. The tip showed a bend. 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 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 pressure waveform to the polaris which indicated 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. Because there was no evidence of any product quality deficiencies, it was considered likely that the kink and tip damage were attributable to handling issues.
Patient Sequence No: 1, Text Type: N, H10
[177856871]
It was reported that chest pain and st segment changes occurred. A percutaneous coronary intervention was being performed on a previously known left anterior descending stent and 100% occluded circumflex artery. An angiogram of the right coronary artery showed an intermediate mid lesion and dfr was performed to determine significance. After equalization, the dfr value distal to the lesion read 0. 81. The comet wire was disconnected and a 3. 0x24mm drug eluding stent was directly implanted over the comet wire to the lesion. A slightly hazy region was noted distal to the stent and another 3. 0x8mm drug eluding stent was implanted on the distal overlap of the first stent to cover the hazy region. The patient started to experience some chest pain and st segment changes at this point. The comet wire was reconnected and another dfr measurement was made resulting in 0. 80. No further intervention was performed and the patient was stabilized and no longer complaining of chest pain when he left the room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00869 |
| MDR Report Key | 9672855 |
| 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 | 2019-11-26 |
| 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 |
| Returned To Mfg | 2020-01-24 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0024835791 |
| 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 | 2020-02-05 |