Brand Name | THERMOCOOL SMARTTOUCH SF |
Type of Device | CARDIAC ABLATION PERCUTANEOUS CATHETER |
Manufacturer (Section D) |
BIOSENSE WEBSTER INC |
31 technology drive, suite 200 |
irvine CA 92618 |
|
MDR Report Key | 19002845 |
MDR Text Key | 338890665 |
Report Number | 19002845 |
Device Sequence Number | 1 |
Product Code |
LPB
|
UDI-Device Identifier | 10846835010183 |
UDI-Public | (01)10846835010183 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
03/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/29/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | D134805 |
Device Catalogue Number | D134805 |
Device Lot Number | 31195880L |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/08/2024 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/29/2024 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 2 MO |
Patient Sex | Male |
Patient Weight | 88 KG |
Patient Race | White |
|
|