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 2020-02-10 for COMET 8900 manufactured by Boston Scientific Corporation.
[179480070]
Device evaluated by mfr: the ffr comet pressure wire was returned without the occ handle. The shaft showed 1 kink located 126cm from the tip. There was peeled coating at the 126cm location. The tip showed damage in the form of a bend. The wire was connected to the test occ handle the signal was present as designed. The sensor housing showed no residue of body fluids. The wire was inserted into the pressure chamber test equipment the pressure sensor functioned as designed. Because there was no evidence of any product quality deficiencies, it was considered likely that the peeled coating was attributable to handling issues; therefore, the conclusion code unintended use error caused or contributed to event has been added.
Patient Sequence No: 1, Text Type: N, H10
[179480071]
Reportable based on the product analysis completed on january 21, 2020. It was reported the device kinked. During advancement of a comet pressure guidewire, the wire kinked in the mid shaft. The wire was removed from the patient and the procedure was completed with another comet with no patient injury. However, the returned product analysis revealed peeled coating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00418 |
| MDR Report Key | 9688141 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-09-25 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| Returned To Mfg | 2019-12-27 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0024493195 |
| 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 | 2020-02-10 |