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 2020-03-26 for TREK RX CORONARY DILATATION CATHETER 1012272-15 manufactured by Abbott Vascular.
[188403297]
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.
Patient Sequence No: 1, Text Type: N, H10
[188403298]
It was reported that the 2. 5x15 mm trek dilatation catheter was advanced to the left anterior descending (lad) coronary artery without resistance through right groin access. When the trek was being pulled back in the lad to position it, resistance was felt and suspected to have been interacting with an older stent in the lad. The shaft of the trek separated during the pull back; the point of separation was inside the guide catheter. Another balloon dilatation catheter was inserted into the guide catheter to try and trap the separated segment, but it met resistance. The left groin was accessed and a guide wire and dilatation catheter were advanced to the trek. The other catheter nudged the separated trek into the guide catheter, which allowed another balloon to advance into the right groin guide catheter to trap the separated segment of the trek. The guide catheter, trek, and trap balloon were removed as a unit from the right groin. The procedure continued through the left groin access. There were no adverse patient sequelae and no clinically significant delay in the procedure. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02964 |
| MDR Report Key | 9884719 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-09-25 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | 1012272-15 |
| Catalog Number | 1012272-15 |
| Lot Number | 90925G4 |
| 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 | 1. Required No Informationntervention | 2020-03-26 |