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 2020-03-25 for HI-TORQUE VERSACORE GUIDE WIRE 1012068-06 manufactured by Abbott Vascular.
[184934926]
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis. Return of the guide wire may have further aided the analysis. A review of the electronic lot history record (elhr) and similar incident query for this product was not performed since the lot number was not reported. Factors that may contribute to a damaged device include, but are not limited to mishandling during manufacturing, mishandling during unpacking at the account and/or mishandling during preparation. Design and manufacturing controls have been established to mitigate possible causes. The investigation was unable to determine a conclusive cause for the reported break. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[184934927]
It was reported that during preparation of the hi-torque versacore guide wire, the coil separated from the white part of the guide wire, the coils did not unravel. It was stated that guide wire did not separate into two pieces. There was no patient involvement. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02887 |
| MDR Report Key | 9880126 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-25 |
| 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 | HI-TORQUE VERSACORE GUIDE WIRE |
| Generic Name | GUIDE WIRE |
| Product Code | DQX |
| Date Received | 2020-03-25 |
| Model Number | 1012068-06 |
| Catalog Number | 1012068-06 |
| 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 | 2020-03-25 |