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 2020-03-20 for HT POWERTURN 1044592 manufactured by Abbott Vascular.
[187718929]
The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[187718930]
It was reported that there was difficulty advancing the powerturn flex guide wire due to the calcium and tortuosity in the mid right coronary artery (rca), but the guide wire was successfully used for the procedure. The mid rca was successfully treated and had been postdilated with a 4. 0x20 mm nc trek. The nc trek was retracted into the guide catheter. The powerturn flex guide wire was retracted without resistance when it broke in the rca. Another powerturn flex guide wire was inserted in order to use a snare to remove the separated wire, but the first guide wire broke again. The middle segment of the separated wire was successfully removed via snare. Attempts made to remove the distal separated wire with another balloon dilatation catheter were not successful. It was decided to implant another stent in the distal rca to embed the separated wire. The unplanned stent was implanted and the procedure was completed. There was no adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02723 |
| MDR Report Key | 9861133 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2020-03-20 |
| 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, REG # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HT POWERTURN |
| Generic Name | GUIDE WIRE |
| Product Code | DQX |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-05 |
| Model Number | 1044592 |
| Catalog Number | 1044592 |
| Lot Number | 9050161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-20 |