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 2020-03-26 for DIREXION FATHOM-16 SYSTEM 84592 manufactured by Boston Scientific Corporation.
[185045754]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[185045755]
It was reported that the tip of the guidewire fractured. A 155cm direxion fathom-16 system was selected for use. During preparation, resistance was noted upon removing the fathom guidewire from the catheter and upon inserting it again. However, the tip of the guidewire was noted to be fractured upon removal. The procedure was completed with the same device. No patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03865 |
| MDR Report Key | 9882722 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-07 |
| Date Mfgr Received | 2020-03-07 |
| Device Manufacturer Date | 2019-07-29 |
| Date Added to Maude | 2020-03-26 |
| 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 CORK LIMITED |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIREXION FATHOM-16 SYSTEM |
| Generic Name | CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2020-03-26 |
| Model Number | 84592 |
| Catalog Number | 84592 |
| Lot Number | 0024178069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-26 |