MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for NC TREK RX UNK NC TREK RX manufactured by Abbott Vascular.
[184844026]
Event estimated date. The udi is unknown because the part and lot numbers were not provided. The device was not returned for evaluation. A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided. The investigation determined the reported deflation issue is related to a manufacturing issue. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices. On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter. The field safety action number is 2024168-1/27/2020-001. This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter. Product from identified lots may exhibit slow, partial or failure to deflate.
Patient Sequence No: 1, Text Type: N, H10
[184844027]
It was reported that during an intervention a 5. 0 nc trek balloon was inflated, but was slow to deflate, the balloon eventually deflated and was removed without issue or impact to the patient. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02835 |
| MDR Report Key | 9875921 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Remedial Action | NO |
| 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 | 2020-03-24 |
| Catalog Number | UNK NC TREK RX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-24 |