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 2020-03-26 for 014 HI-TORQUE PILOT 1010480-HJ manufactured by Abbott Vascular.
[188403674]
The product was not returned. 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 reported from this lot for irregular texture. A conclusive cause for the reported irregular texture or too much lubricity cannot be determined. The reported patient effect of perforation is listed in the guide wire hi-torque instructions for use ce fda as a known patient effect of the procedure. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[188403675]
It was reported that the pilot guide wire was advanced without difficulty to the calcified and tortuous lesion in the left circumflex coronary artery in the patient with an acute myocardial infarction. The physician commented that the guide wire was very lubricious and it was necessary to hold it. Multiple balloons were used to predilate the lesion, but a stent was unable to reach the lesion due to the vessel calcification. The procedure was completed with balloon angioplasty only, but a vessel perforation occurred. It is suspected that the pilot guide wire is related to the perforation. No treatment was required for the perforation. The patient is in stable condition. There was no adverse patient sequelae. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02944 |
| MDR Report Key | 9884068 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-04-01 |
| Device Manufacturer Date | 2019-06-11 |
| 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, REG # 3005737652 |
| Manufacturer Street | ROAD NO.2 KM 58.0 CRUCE D |
| Manufacturer City | BARCELONETA PR 00617 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00617 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 014 HI-TORQUE PILOT |
| Generic Name | GUIDE WIRE |
| Product Code | DQX |
| Date Received | 2020-03-26 |
| Model Number | 1010480-HJ |
| Catalog Number | 1010480-HJ |
| Lot Number | 9061171 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2020-03-26 |