ULTRAVERSE 014
Received Jul 15, 2026 · Event occurred Jun 18, 2026
Report 2020394-2026-01809 · MDR key 25824069
Device
Generic name
Pta Balloon Dilatation Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
U41502H10
Lot number
CMLN0153
Product problems
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
ON (B)(6) 2026, IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE UTILIZING AN ULTRAVERSE 014 BALLOON CATHETER. DURING THE PROCEDURE, A GLUE LIKE SUBSTANCE WAS OBSERVED ON THE BALLOON SURFACE. THERE WAS NO REPORTED PATIENT INJURY.