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 2020-03-27 for HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING 1005357H manufactured by Abbott Vascular.
[188551609]
The incident information was reviewed; 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), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the lot number was not reported. There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties. The investigation determined the reported difficulty to advance/position the guide wire resulting in a tip separation appears to be related to operational circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling. The 3. 0x38mm xience is being filed under a separate medwatch report #.
Patient Sequence No: 1, Text Type: N, H10
[188551610]
It was reported that the procedure was to treat a heavily calcified mid left anterior descending (mlad) artery. During advancement of a whisper guide wire the tip became trapped with an implanted 3. 0x38mm xience stent that was implanted in the same procedure. The physician pulled back the guide wire and became separated. The tip was embedded into the vessel wall with two more xience stents. There were no adverse patients sequela and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03053 |
| MDR Report Key | 9891875 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-27 |
| 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 | HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING |
| Generic Name | GUIDE WIRE |
| Product Code | DQX |
| Date Received | 2020-03-27 |
| Model Number | 1005357H |
| Catalog Number | 1005357H |
| 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 | 1. Required No Informationntervention | 2020-03-27 |