Transitionless Micro-Introducer Kit KIT-038-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841268104549), received between Nov 30, 2018 and Nov 9, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023

  DURING AN ATTEMPT TO PLACE A MIDLINE CATHETER, THE GUIDEWIRE BECAME STUCK IN THE PATIENT'S ARM (NOTED TO BE LOCATED IN SUBCUTANEOUS TISSUE). THERE WAS DIFFICULTY IN BACKING THE WIRE OUT, THEREFORE, VASCULAR SURGERY WAS CONSULTED. AS ATTEMPTS WERE BEING MADE AT WIRE REMOVAL BY VASCULAR SURGERY, THE WIRE BROKE. A MEDICAL DECISION WAS MADE TO LEAVE THE BROKEN PIECE OF THE WIRE INSIDE THE PATIENT. THIS WAS REPORTED AS THE 3RD TIME IN WHICH THIS PROCEDURALIST HAS SEEN THE WIRE TIP ENCIRCLE ITSELF INTO FORMING A SMALL KNOT. IN THE PREVIOUS 2 CASES, THE WIRE WAS SIMPLY REMOVED. IN THIS CASE, THE WIRE BECAME STUCK AND REQUIRED CONSULTATION BY VASCULAR SURGERY AND A TRIP TO THE OPERATING ROOM FOR ATTEMPTED REMOVAL OF THE WIRE. NOTE: THIS GUIDEWIRE WAS USED WHILE ATTEMPTING TO PLACE A BARD POWERMIDLINE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 18122243 ↗
• MalfunctionDec 17, 2018Break

  AS RECEIVED FROM HEALTH PROFESSIONAL: PATIENT WAS PREPPED/ DRAPED IN STERILE FASHION. PER CARDIOLOGIST'S NOTES: A PERCUTANEOUS NEEDLE STICK WAS ACHIEVED THROUGH THE LEFT SUBCLAVIAN VEIN. A GUIDEWIRE WAS THEN INSERTED INTO THE LEFT SUBCLAVIAN VEIN. RESISTANCE WAS MET AND WHILE RETRACTING THE WIRE, THE TIP BROKE OFF. CONTRAST ANGIOGRAPHY WAS PERFORMED DEMONSTRATING THAT THE WIRE WAS NOT INTRAVASCULAR. ACCESS WAS THEN AGAIN ACHIEVED VIA MICROPUNCTURE UNDER ANGIOGRAPHY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171754 ↗
• MalfunctionNov 30, 2018Break; Physical Resistance/Sticking

  PATIENT WAS PREPPED/ DRAPED IN STERILE FASHION. PER CARDIOLOGIST'S NOTES: A PERCUTANEOUS NEEDLE STICK WAS ACHIEVED THROUGH THE LEFT SUBCLAVIAN VEIN. A GUIDEWIRE WAS THEN INSERTED INTO THE LEFT SUBCLAVIAN VEIN. RESISTANCE WAS MET AND WHILE RETRACTING THE WIRE, THE TIP BROKE OFF. CONTRAST ANGIOGRAPHY WAS PERFORMED DEMONSTRATING THAT THE WIRE WAS NOT INTRAVASCULAR. ACCESS WAS THEN AGAIN ACHIEVED VIA MICROPUNCTURE UNDER ANGIOGRAPHY. MANUFACTURER RESPONSE FOR PERCUTANEOUS SHEATH INTRODUCER KIT, TRANSITIONLESS MICRO-INTRODUCER KIT (PER SITE REPORTER). REPORTED BY THE CARDIAC CATH LAB MANAGER TO MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8119529 ↗