Adelante Sigma ASG06010Recalls & reported problems
Oscor Inc. · Introducer Set with Hemostatic Valve, 6F · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10836559007392), received between Oct 3, 2017 and Oct 3, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2017Break; Break
WHAT WAS THE OD OF THE BALLOON? MEDTRONIC DCB - 5MM X 150 MM -5MM X 120MM. WAS THE DEVICE TIP FINE DURING INITIAL INSERTION? SEEMED TO BE NORMAL, THERE WAS A PROBLEM WITH INSERTION AND HAD TO CUT SKIN AND INSERT. HOW AND AT WHAT POINT WAS THE TIP BROKEN? WHEN REMOVING THE BALLOON. THE BALLOON GOT STUCK- BALLOON AND SHEATH WERE REMOVED TOGETHER. 0.18 WIRE TO OPEN THE SHEATH- AND DID NOT WANT TO GO THROUGH DUE TO THE CONSTATINA OF THE SHEATH FROM TRYING TO REMOVE THE BALLOON. HOW WAS THE TIP BROKEN? BALLOON GOT STUCK AROUND THE TIP OF THE SHEATH AND THE SHEATH WAS CUT TO REMOVE THE TIP AND THE BALLOON AFTER A NUMBER OF TIMES TRYING TO REMOVE THE BALLOON FROM/THROUGH THE SHEATH. HOW WAS THE INITIAL SHEATH/DILATOR PLACED INTO POSITION? INTRODUCED INTO SKIN, HAD TO CUT SKIN AS SHEATH DID NOT WANT TO GO INTO THE VESSEL. WHAT OTHER PRODUCTS WERE USED WITH THE INTRODUCER SHEATH? BAROC 0.14 BALLOONS TO PREPARE VESSEL. AFTER OPERATION: FOOT AMPUTATION AND LATER ON BELOW THE KNEE AMPUTATION. DOCTOR HAS SAID THAT THE AMPUTATIONS HAD NOTHING TO DO WITH THE ANGIOPLASTY, IT IS JUST THE NATURE OF THE DISEASE. ADDITIONALLY, THE DOCTOR HAS THOUGHT THAT THE SHEATH DIAMETER WAS NOT ACTUALLY THAT OF A
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 6911803 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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