Advance G30968Recalls & reported problems
Cook Incorporated · Advance, 18LP Low Profile PTA Balloon Dilatation Catheter · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002309682), received between Jan 31, 2024 and Jan 31, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2024Material Separation; Material Separation
AS REPORTED, DURING AN ANGIOGRAM WITH DILATION, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER¿S BALLOON SEPARATED IN THE PATIENT UPON REMOVAL OF THE DEVICE. A COOK 6-FRENCH SHEATH WAS USED DURING THE PROCEDURE. AN UNSPECIFIED INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME TO EIGHT ATMOSPHERES, WITHIN A LESION IN THE CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS NOT TOTALLY OCCLUDED. AFTER INFLATION, THE DEVICE WAS DEFLATED AND ALLOWED TO RETURN TO AMBIENT PRESSURE, WITH NEGATIVE PRESSURE MAINTAINED. THE BALLOON CATHETER WAS PULLED BACK OVER A WIRE GUIDE; HOWEVER, UPON REMOVAL OF THE DEVICE, THE BALLOON RIPPED IN HALF AND DETACHED INSIDE THE PATIENT. IT IS UNKNOWN IF A COUNTERCLOCKWISE ROTATION OF THE BALLOON CATHETER WAS CONDUCTED UPON REMOVAL. THE SEPARATED BALLOON MATERIAL WAS REMOVED WITH A SNARE, WITH NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. THE PATIENT¿S OUTCOME WAS GOOD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18617964 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.