MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-12 for COMET 8900 manufactured by Boston Scientific Corporation.
[179737930]
Returned product consisted of an ffr comet pressure wire connected to the optical cable connection (occ). The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities. The wire shaft showed a kink located 134cm from the tip. There was peeled coating at the 134cm location. The occ handle was connected to the ffr link for signal verification. The signal was not present as designed. Device analysis was conducted by inspecting the proximal end of the wire for any damage to the fiber optic. No damage was noticed. The sensor was inspected by viewing the sensor port to verify that the sensor was in the correct location. This sensor looked to be too far distal which would give the indication of the sensor being detached from the fiber optic cable. The wire was gently shaken to see if the sensor would move within the sensor housing and the sensor did move which verifies the sensor was detached from the fiber optic. The coefficient was confirmed to be in specification. 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
[179737931]
Reportable based on analysis completed on 28jan2020. It was reported that a connection issue occurred. During preparation for a percutaneous coronary intervention procedure. This comet pressure guidewire was selected; however, the pressure wire failed to connect to the ffr system. The procedure was completed with another of the same device. No patient complications were reported. However, device analysis revealed peeled coating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01356 |
| MDR Report Key | 9701952 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-08-13 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | 2020-02-12 |
| Returned To Mfg | 2020-01-13 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0024258300 |
| 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 | 2020-02-12 |