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 1012455-08 manufactured by Abbott Vascular.
[187867609]
(b)(4). The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[187867610]
It was reported that the procedure was performed to treat a lesion in the left main coronary artery. An unspecified stent was implanted without issue. The 5. 0 x 8 mm nc trek dilatation catheter was advanced and inflated for post dilatation. No issues were noted during inflation and on angiography, it appeared that the balloon fully deflated. An attempt was made to remove the dilatation catheter; however, it appeared that the balloon was stuck on the stent. The physician pulled on the dilatation catheter, and a separation occurred, at a location inside the patient anatomy. The portion remaining outside the anatomy was removed. A second dilatation catheter was advanced and inflated, trapping the separated portion of the dilatation catheter and pulling it into the guide catheter. All devices were removed without issue. There were no adverse patient sequelae and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02845 |
| MDR Report Key | 9876086 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2020-01-15 |
| 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 |
| 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 |
| Returned To Mfg | 2020-03-11 |
| Model Number | 1012455-08 |
| Catalog Number | 1012455-08 |
| Lot Number | 00115G1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2020-03-24 |