MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for NC TREK RX 1012453-12 manufactured by Abbott Vascular.
[185726131]
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The additional 4x15mm, 3. 5x15mm nc trek devices referenced are filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10
[185726132]
It was reported that the procedure was to treat an unspecified lesion. Three (4x15mm, 3. 5x15mm, and 4x12mm) nc trek balloon dilatation catheters were attempted to be inserted when the shaft for all three devices became separated. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03137 |
| MDR Report Key | 9903792 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2020-01-09 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR COSTA RICA, REG # 3009564766 |
| Manufacturer Street | 52 CALLE 3 B31 COYOL FREE ZONE |
| Manufacturer City | EL COYOL ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NC TREK RX |
| Generic Name | CORONARY DILATATION CATHETER |
| Product Code | LOX |
| Date Received | 2020-03-31 |
| Model Number | 1012453-12 |
| Catalog Number | 1012453-12 |
| Lot Number | 00109G1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |