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 2020-01-08 for COMET 8900 manufactured by Boston Scientific Corporation.
[177850052]
Device returned to manufacturer: the comet pressure guidewire was returned and analysis was completed. The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities. The wire showed kinks on the shaft located 113. 5cm and 175. 5cm from the tip and at the occ handle. There was some peeled coating at the 175. 5cm location. The tip showed bend damage and stretched coils. The occ handle was connected to the ffr link for signal verification. The signal was not present as designed. The sensor port was inspected to verify that the sensor was connected to the fiber optic. It was noticed that the sensor was in the correct location in the sensor port. The wire was gently moved back and forth to see if the sensor would move. The sensor did not move which verifies that the fiber optics were connected to the sensor. The proximal end of the wire was inspected for any fiber optic cracks or damage and that is was polished correctly. The wire end showed no damage. The guidewire tip was removed to view the sensor and to verify that the sensor was not cracked or damaged. The sensor appeared to be cracked and showed damage. The occ handle cap was loosened to remove the wire. There was no issue with removing the wire. The sensor port showed residue of body fluids. 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
[177850053]
Reportable based on analysis completed 18 dec 2019. It was reported that the error message 3015 was displayed and the comet pressure guidewire could not be used. Returned device analysis revealed some slight peeling of the device coating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-16528 |
| MDR Report Key | 9566256 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2019-07-12 |
| Date Added to Maude | 2020-01-08 |
| 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 | 2020-01-08 |
| Returned To Mfg | 2019-12-03 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0024100281 |
| 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 | 2020-01-08 |