Biotronik Fortress Introducer Sheath System 45 cm, 6F StraightRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04251244500078), received between Aug 9, 2018 and Feb 8, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component

  THE CUSTOMER REPORTED AS FOLLOWS: "LITTLE GREEN CAP WITH HOLE IN MIDDLE ON THE SIDE OF THE DEVICE POPPED OFF DURING PROCEDURE. BECAUSE OF THIS, A LOT OF BLOOD WAS LOST AND A TRANSFUSION HAD TO BE DONE." EVENT OCCURRED INSIDE PATIENT. DEVICE PARTS DIDN'T REMAIN IN THE PATIENT. THERE IS PATIENT INJURY AND BLOOD TRANSFUSION NEEDED, DUE TO LOSS OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668382 ↗
• MalfunctionDec 10, 2019Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  EVENT DESCRIPTION PROVIDED BY CUSTOMER REPRESENTATIVE: "THE FORTRESS 6F INTRIDUCER BROKE OUTSIDE THE PATIENT DURING WITHDRAWAL. AS IT WAS BLEEDING A LOT THE ARTERIA HAD TO BE CLAMPED. THEN IT WAS TRIED TO REMOVE THE INTRODUCER SHEATH AGAIN BUT THE FORTRESS BROKE INSIDE THE PATIENT AGAIN. THEREFORE THE PATIENT HAD TO BE SEND TO ANOTHER HOSPITAL FOR EMERGENCY." EVENT DETAILED DESCRIPTION ACCORDING BIOTRONIK COMPLAINT NOTIFICATION FORM ID: (B)(4). "VIA RADIAL ARTERY. THE FORTRESS 6F INTRODUCER (45CM) BROKE OUTSIDE THE PATIENT AT WITHDRAWAL. ARTERIA WAS SPASME-ASSOCIATED. SO THE WITHDRAWAL WAS DIFFICULT, BUT IT HAPPENS OFTEN. AS THE VALVA WAS OUT OF ORDER, IT WAS BLEEDING A LOT. THE PHYSICIAN NEEDED TO CLAMP THE ARTERIA. HE TRIED AGAIN TO REMOVE THE INTRODUCER BUT IT BROKE AGAIN INSIDE THE PATIENT. THE PATIENT HAS BEEN HOSPITALIZED IN ANOTHER HOSPITAL IN EMERGENCY. TODAY THE PATIENT SUFFERS FROM AN EDEMA IN THE FOREARM AND PARESTHESIA ALSO IN THE FOREARM. THE PATIENT IS STILL AT HOSPITAL."

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque; Edema; Hemostasis; Numbness

  MAUDE report 9443137 ↗
• MalfunctionFeb 12, 2019Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  THE DOCTOR SAID THAT THE PATIENT HAD PREVIOUS SURGERY TO THE GROIN SO THERE WAS SOME SCARRING BUT NO CALCIFICATION AND A VEIN PATCH TO THE ARTERY. HE USED AN ULTRASOUND TO PUNCTURE THE ARTERY AT THE SITE OF THE VENOUS PATCH. THERE WAS SLIGHT RESISTANCE WHEN HE SWAPPED THE SHORT SHEATH FOR THE 6F 45CM FORTRESS BUT WAS NOT CONCERNED BY THIS. ONCE HE WENT TO REMOVE THE SHEATH HE FELT MORE RESISTANCE AND COULD SEE THAT THE SHEATH WAS ELONGATING. AT THIS POINT HE INSERTED THE DILATOR AND SWAPPED TO A STIFF LUNDERQUIST WIRE (COOK)TO OFFER MORE SUPPORT. UNFORTUNATELY THIS DID NOT STOP THE SHEATH FROM ELONGATING FURTHER AND SNAPPING INTO 2 PARTS. HE NEEDED TO CUT DOWN INTO THE GROIN SUPERFICIALLY WHERE HE WAS ABLE TO LOCATE THE DISTAL PORTION OF THE SHEATH AND REMOVE IT. HE WAS ABLE TO SUTURE THE FEMORAL PUNCTURE AND OVERSEW THE SMALL INCISION IN THE SKIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331224 ↗
• MalfunctionOct 2, 2018Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  THE MANUFACTURER WAS INFORMED, THAT DURING REMOVAL OF THE SHEATH, THERE WAS A RESISTANCE. THE SHEATH STARTED TO ELONGATE AND THEN CAME APART ABOUT 10 CM FROM THE HUB. THE ARTERY FORCEPS WERE USED TO REMOVE THE REST OF THE SHEATH AND NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925464 ↗
• MalfunctionAug 9, 2018Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  THE CUSTOMER INITIALLY PROVIDED CMI (MANUFACTURER) WITH THE FOLLOWING PROBLEM DESCRIPTION ON 07/11/2018: AT THE END OF THE PROCEDURE WHEN THE DR WAS WITHDRAWING THE SHEATH, THERE WAS RESISTANCE AND THE PATIENT WAS COMPLAINING OF 10/10 PAIN. AS HE CONTINUED TO WITHDRAW THE SHEATH IT APPEARED TO "UNRAVEL". PT REQUIRED FURTHER ANALGESIA AND IMAGING TO ENSURE THAT NO REMNANTS WERE LEFT IN THE PATIENT. ON 07/18/2018, THE CUSTOMER PROVIDED CMI WITH ADDITIONAL INFORMATION: I HAD A FURTHER CONVERSATION WITH THE DR YESTERDAY. THE PATIENTS GROIN WAS VERY SCARRED AND HAD A VENOUS BYPASS GRAFT. IT TRACKED OK ON INTRODUCTION TO THE ARTERY VIA THE BYPASS. IT WAS ON WITHDRAWAL THAT THE RESISTANCE WAS ENCOUNTERED. THEY NOTICED THAT THE SHEATH WAS WITHDRAWING (OR APPEARED TO BE) BUT ON IMAGING THE DISTAL OPAQUE MARKER WAS NOT MOVING. THIS IS WHEN HE REALISED THAT THE SHEATH WAS UNCOILING OR "STRETCHING" DUE TO THE RESISTANCE. HE DID REINTRODUCE THE DILATOR, HOWEVER THE SHEATH HAD STRETCHED SO THE DILATOR DID NOT REACH THE DISTAL TIP. IT DID HELP TO WITHDRAW THE SHEATH FURTHER. HE DID REQUIRE TO USE ARTERY FORCEPS TO GET ENOUGH TRACTION OR "GRIP " ON THE SHEATH TO WITHDRAW FULLY AND THIS IS WHEN THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7766890 ↗