Brand Name | RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH. |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
TERUMO CORPORATION, ASHITAKA |
150 maimaigi-cho |
fujinomiya city, shizuoka 418 |
JA 418 |
|
Manufacturer (Section G) |
TERUMO CORPORATION, ASHITAKA |
reg. no. 9681834 |
150 maimaigi-cho |
fujinomiya city, shizuoka 418 |
JA
418
|
|
Manufacturer Contact |
terry
callahan
|
reg. no. 2243441 |
2101 cottontail ln. |
somerset, NJ 08873
|
8002837866
|
|
MDR Report Key | 6979351 |
MDR Text Key | 90324111 |
Report Number | 9681834-2017-00233 |
Device Sequence Number | 1 |
Product Code |
DQO
|
UDI-Device Identifier | 04987350772473 |
UDI-Public | 04987350772473 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K915414 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/26/2017 |
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 | CG508 |
Device Catalogue Number | RF*XL95110A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/02/2017
|
Initial Date FDA Received | 10/26/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | AZUR COILS |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 84 YR |
Patient Weight | 85 |