| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HT BALANCE GUIDE WIRE | GUIDE WIRE | ABBOTT VASCULAR | DQX | 1001780-HC | 1001780-HC | 9092071 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-20 | 0 |
Patient 1
THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE FIRST BMW GUIDE WIRE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.
Patient 1
IT WAS REPORTED THAT FIRST BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE WAS ADVANCED TOWARDS THE RIGHT CORONARY ARTERY, BUT THE GUIDE WIRE WAS UNABLE TO CROSS THE ARTERY AND BECAME KINKED. IT WAS DIFFICULT TO REMOVE THE GUIDE WIRE FROM THE ANATOMY. A SECOND BMW GUIDE WIRE WAS INSERTED AND HAD THE SAME ISSUE AS THE FIRST BMW GUIDE WIRE. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient 1
THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. 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 DIFFICULTIES APPEARS TO BE RELATED TO OPERATIONAL CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.