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 1012450-15 manufactured by Abbott Vascular.
[186377310]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186377311]
It was reported that the procedure was performed to treat a mildly calcified, mildly tortuous de novo left anterior descending artery that was 80% stenosed. The 3. 25x15mm nc trek balloon was inflated a few times (exact number not given) at 20 atmospheres (atm) then the balloon ruptured at 20 atm. A new unspecified balloon was used to successfully complete the procedure. 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
[188933632]
A visual inspection was performed on the returned device. The balloon rupture was confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: balloon pressure should not exceed the rated burst pressure (rbp). The investigation determined the reported balloon rupture appears to be related to the violation of the ifu as the nc trek bdc was over inflated to 20 atmospheres (atms) multiple times. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024168-2020-03140 |
| MDR Report Key | 9904437 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-09-28 |
| 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 | 1012450-15 |
| Catalog Number | 1012450-15 |
| Lot Number | 90928G1 |
| 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 |