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Received Jul 9, 2026 · Event occurred May 28, 2026
Report 3011642792-2026-00107 · MDR key 25764151
Device
Generic name
Haemostasis Valve
Manufacturer
Merit Medical Systems, Inc.Catalog number
MAP152/CNF
Lot number
I3199386
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
THE SUSPECTED DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
ON (B)(6) 2026, A NURSE IN THE INTERVENTIONAL DEPARTMENT FOLLOWED THE DOCTOR'S ORDERS TO USE THE ANGIOPLASTY KIT FOR A POST-PROCEDURE CATHETERIZATION PATIENT. AFTER SENDING THE PATIENT TO THE WARD, BLEEDING WAS OBSERVED. THE PATIENT WAS IMMEDIATELY RETURNED TO THE INTERVENTIONAL OPERATING ROOM, THE MICROCATHETER WAS WITHDRAWN, A NEW ANGIOPLASTY KIT WAS REPLACED, AND THE OPERATION WAS COMPLETED. CAUSE ANALYSIS OF EVENT: PRODUCT-RELATED (INCLUDING INSTRUCTIONS, ETC.) DESCRIPTION OF CAUSE ANALYSIS: KIT ISSUE: THE CONNECTIONS OF THE CATHETER, GUIDEWIRE, AND OTHER COMPONENTS OF THE KIT WERE NOT TIGHT, OR THERE WERE QUALITY PROBLEMS WITH THE KIT, WHICH COULD LEAD TO BLEEDING. INITIAL HANDLING: REPLACED WITH A NEW ANGIOPLASTY KIT AND COMPLETED THE OPERATION.