Brand Name | JADE PTA BALLOON DILATATION CATHETER |
Type of Device | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER |
Manufacturer (Section D) |
ORBUSNEICH MEDICAL CO. LTD |
1 jinkui road, |
futian free trade zone |
shenzhen 518038,, shenzhen 518038, 51803 8 |
CH 518038 |
|
MDR Report Key | 12047595 |
MDR Text Key | 257747596 |
Report Number | 3014148220-2021-02145 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial |
Report Date |
06/23/2021 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | L540-50240 |
Device Lot Number | 5303752104 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 06/18/2021 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/23/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|