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 2020-03-25 for TREK RX CORONARY DILATATION CATHETER 1012270-12 manufactured by Abbott Vascular.
[185001658]
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[185001659]
It was reported that the procedure was to treat a moderately tortuous, mildly calcified, de novo lesion in the left posterior ventricular artery. The 2. 0 x 12mm mini trek rx balloon dilatation catheter (bdc) was advanced for pre-dilation of the lesion. After two attempts to pre-dilate the lesion, contrast was seen leaking from the balloon. The bdc was removed from the anatomy and the leak was confirmed when the balloon was inflated outside the anatomy. A new bdc was used. There were no adverse patient effects. No additional information was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02906 |
| MDR Report Key | 9881395 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-09-04 |
| Date Added to Maude | 2020-03-25 |
| 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 | TREK RX CORONARY DILATATION CATHETER |
| Generic Name | CORONARY DILATATION CATHETER |
| Product Code | LOX |
| Date Received | 2020-03-25 |
| Model Number | 1012270-12 |
| Catalog Number | 1012270-12 |
| Lot Number | 90904G2 |
| 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 | 2020-03-25 |