Brand Name | CORONARY DILATATION CATHETER |
Type of Device | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
Manufacturer (Section D) |
|
MDR Report Key | 10179818 |
MDR Text Key | 196201930 |
Report Number | MW5095132 |
Device Sequence Number | 1 |
Product Code |
LOX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
06/18/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2021 |
Device Model Number | 5.00 MM X 12 MM, 145 CM |
Device Catalogue Number | 1012280-12 |
Device Lot Number | 80615G1 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/19/2020 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 74 YR |
Patient Weight | 54 |
|
|