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 2020-01-07 for COMET 8900 manufactured by Boston Scientific Corporation.
[177631766]
Device returned to manufacturer: the comet was returned without the handle and analysis was completed. The tip, device shaft and sensor port were examined for damage or any irregularities. The investigation of the shaft of the device showed no damage. The tip showed a bend. It was noticed that there was some peeling of the coating located 81cm from the tip and continued along the shaft to 131cm. 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 peeled coating and the tip damage was attributable to handling issues; therefore, the conclusion code unintended use error caused or contributed to event.
Patient Sequence No: 1, Text Type: N, H10
[177631768]
It was reported that foreign matter was noted after a procedure. A procedure had been completed with the use of a comet pressure guidewire. Upon removing the comet from the y adaptor, it was wiped with a saline gauze material. It was noticed that a lot of black sediment was on the gauze thereafter. No injury was encountered by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-15879 |
| MDR Report Key | 9559325 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2019-07-12 |
| Date Added to Maude | 2020-01-07 |
| 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 | 2020-01-07 |
| Returned To Mfg | 2019-12-23 |
| 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 | 2020-01-07 |