Brand Name | ANGIOJET ULTRA 5000A |
Type of Device | CATHETER, CORONARY, ATHERECTOMY |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
MINNETRONIX |
1635 energy park drive |
|
st. paul MN 55108 |
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 9432503 |
MDR Text Key | 169682077 |
Report Number | 2134265-2019-15196 |
Device Sequence Number | 1 |
Product Code |
MCX
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P980037 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/06/2019 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/22/2019
|
Initial Date FDA Received | 12/06/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | ANGIOJET SOLENT OMNI THROMBECTOMY CATHETER |
Patient Outcome(s) |
Other;
|