Brand Name | RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC, |
Manufacturer (Section D) |
TERUMO CORPORATION, ASHITAKA |
150 maimaigi-cho |
fujinomiya city, 418 |
JA 418 |
|
MDR Report Key | 18463824 |
MDR Text Key | 332299277 |
Report Number | 2243441-2023-00052 |
Device Sequence Number | 1 |
Product Code |
DQO
|
UDI-Device Identifier | 04987350772190 |
UDI-Public | 04987350772190 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | CG415 |
Device Lot Number | 230206 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/05/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/08/2024 |
Distributor Facility Aware Date | 08/24/2023 |
Device Age | 5 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/29/2023 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 01/08/2024 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | SNARE. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 76 YR |
Patient Sex | Male |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|