MEDLINE
Received Jun 8, 2026 · Event occurred Mar 11, 2026
Report 1423395-2026-00239 · MDR key 25428638
Device
Generic name
Dbd-venclose Micro Intro Kit, 7cm
Manufacturer
Medline Industries, LpCatalog number
VC-ISH-6F7
Lot number
25EBK836
Product problems
- Break
- Material Integrity Problem
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT ON (B)(6) 2026, "A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE MICRO INTRO KIT 7CM. DURING THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY BROKE INSIDE THE PATIENT'S VEIN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN". IT WAS REPORTED THAT, "THE PATIENT WAS ADMITTED TO THE HOSPITAL TO GET THE GUIDEWIRE REMOVED FROM THE VEIN". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026, "A PATIENT UNDERWENT A RADIO FREQUENCY ABLATION PROCEDURE USING THE VENCLOSE MICRO INTRO KIT 7CM. DURING THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY BROKE INSIDE THE PATIENT'S VEIN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN".