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 2020-03-24 for TREK RX CORONARY DILATATION CATHETER 1012272-15 manufactured by Abbott Vascular.
[184844161]
(b)(4). The device was not returned for evaluation. 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 was reported that the balloon was not soaked prior to use. It should be noted that the coronary dilatation catheters (cdc), trek rx global instructions for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating. In this case, it is unknown if the ifu violation caused or contributed to the reported complaint. The investigation was unable to determine a conclusive cause for the reported difficulty. 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
[184844162]
It was reported that during device preparation, the balloon was not soaked. The procedure was to treat a mildly calcified, mildly tortuous lesion in the mid-left anterior descending (lad) artery. A 2. 5x15mm rx trek balloon dilatation catheter (bdc) was advanced through the stent struts and the kissing balloon technique was attempted. When negative pressure was pulled, blood was noted in the device. The bdc was removed and another device was used to successfully complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effect. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02846 |
| MDR Report Key | 9876109 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-11-01 |
| 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 |
| Model Number | 1012272-15 |
| Catalog Number | 1012272-15 |
| Lot Number | 91101G1 |
| 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 | 2020-03-24 |