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 2020-03-24 for TREK RX CORONARY DILATATION CATHETER 1012276-15 manufactured by Abbott Vascular.
[184843526]
The investigation was unable to determine a conclusive cause for the reported inflation issue. Return device analysis noted that the inner member and outer member (shaft) were stretched proximal to the proximal seal. In this case, it is possible that the noted stretched shaft contributed to the reported inflation issue; however, it is unknown when the stretching occurred, and it was reported that the device was successfully used in the anatomy. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
Patient Sequence No: 1, Text Type: N, H10
[184843527]
It was reported that the procedure was to treat a mildly calcified, mildly tortuous and 50% stenosed lesion in the left anterior descending (lad) artery. A 3. 50x15mm rx trek balloon dilatation catheter (bdc) was successfully used in the anatomy. When it was removed from the anatomy an attempt was made to inflate the balloon to check the balloon re-wrap, but it could only be partially inflated. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Device analysis captured that the inner and outer members were stretched proximal to the proximal seal. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02830 |
| MDR Report Key | 9875885 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-08-28 |
| 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 | TREK RX CORONARY DILATATION CATHETER |
| Generic Name | CORONARY DILATATION CATHETER |
| Product Code | LOX |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 1012276-15 |
| Catalog Number | 1012276-15 |
| Lot Number | 90828G1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-24 |