MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for NC TREK RX 1012445-08 manufactured by Abbott Vascular.
[186380151]
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis. 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 reported from this lot. In this case, the device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use. The investigation determined the reported failure to advance and balloon rupture appear to be related to circumstances of the procedure. Based on the reported information, during advancement the balloon catheter encountered resistance with the heavily calcified, moderately tortuous anatomy. It is likely that during advancement the balloon became damaged or compromised causing the balloon to rupture the first inflation at 18 atmospheres. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[186380152]
It was reported that the procedure was to treat a de novo lesion in the heavily calcified, moderately tortuous posterior descending coronary artery. The 2. 00x8 mm nc trek balloon dilatation catheter (bdc) was advanced with resistance with the anatomy noted and inflated once to 18 atmospheres for 10 seconds and ruptured due to the heavy calcium. A non-abbott bdc was used to continue the procedure. There were no adverse patient effects and there was no reported clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03165 |
| MDR Report Key | 9907980 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-10-22 |
| 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 | 1012445-08 |
| Catalog Number | 1012445-08 |
| Lot Number | 81022G1 |
| 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 | 2020-03-31 |