| Brand Name | SCOREFLEX NC SCORING PTCA CATHETER |
|---|
| Type of Device | CUTTING/SCORING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER |
|---|
| Manufacturer (Section D) |
| ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. |
| no. 1 jinkui road, futian free |
| shenzhen, 51803 8 |
| CH 518038 |
|
|---|
| MDR Report Key | 17558739 |
|---|
| MDR Text Key | 321273687 |
|---|
| Report Number | 3004742232-2023-00212 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
NWX
|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | US |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Distributor
|
|---|
| Reporter Occupation |
Physician
|
|---|
| Type of Report
| Initial |
|---|
| Report Date |
08/16/2023 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Date FDA Received | 08/16/2023 |
|---|
| Is this an Adverse Event Report? |
Yes
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
|---|
| Device Model Number | 630-154-1U |
|---|
| Device Catalogue Number | 7-10082-17 |
|---|
| Device Lot Number | 3641292212 |
|---|
| Was Device Available for Evaluation? |
Yes
|
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
Yes
|
|---|
| Date Report Sent to FDA | 08/16/2023 |
|---|
| Distributor Facility Aware Date | 07/25/2023 |
|---|
| Event Location |
Hospital
|
|---|
| Date Report to Manufacturer | 08/16/2023 |
|---|
| Is This a Reprocessed and Reused Single-Use Device? |
No
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Outcome(s) |
Required Intervention;
|
| Patient Age | 78 YR |
|---|
| Patient Sex | Male |
|---|
| Patient Weight | 95 KG |
|---|
| Patient Race | White |
|---|
|
|
