AcQCross Qx 900304Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850027837147), received between Jun 7, 2023 and Nov 21, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Advance” (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

Recent adverse event reports

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

• InjuryNov 21, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, RESISTANCE WAS NOTED WHEN ATTEMPTING TO ACCESS THE RIGHT FEMORAL VEIN. THE ROOM STAFF WERE INSTRUCTED ON PROPER PREP AND USE OF THE FLEXCATH CROSS SYSTEM. THE PHYSICIAN WAS INSTRUCTED ON PROPER PREP, BEST PRACTICES AND RISK MITIGATION WHEN USING THE FLEXCATH CROSS SYSTEM. WHEN ATTEMPTING TO ACCESS THE RIGHT FEMORAL VEIN WITH THE FLEXCATH CROSS SYSTEM, RESISTANCE WAS MET, AND THE PHYSICIAN CONTINUED TO PUSH FORCE AGAINST THE RESISTANCE. THE PHYSICIAN WAS INSTRUCTED TO STOP, REASSESS, AND DILATE THE ACCESS SITE IF NEEDED. THE PHYSICIAN NOTED A KINK ON THE GUIDEWIRE WAS PRESENT WHEN THE FLEXCATH CROSS SYSTEM WAS PULLED OUT. THE GUIDEWIRE WAS REPLACED WITH A NON-MEDTRONIC GUIDEWIRE WHICH RESOLVED THE ISSUE. THE PHYSICIAN DILATED THE ACCESS SITE AND REINSERTED THE FLEXCATH CROSS WITHOUT ANY FURTHER ISSUES. TRANSSEPTAL WAS ACHIEVED AND PROCEDURE COMPLETED. A LATER COMMUNICATION WAS RECEIVED FROM THE HOSPITAL STATING THAT THE PATIENT HAD GROIN COMPLICATIONS REQUIRING SURGERY. THE PHYSICIAN WAS AWARE THAT THE PRODUCT WAS NOT A DIRECT CAUSE OF THE ISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18187353 ↗
• InjuryAug 28, 2023Material Deformation; Material Deformation

  IT WAS INITIALLY REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE EXPERIENCED A KINK, LEADING TO A SUBSEQUENT KINK IN THE SHEATH. PER THE PHYSICIAN, THIS SERIES OF EVENTS RESULTED IN A PERFORATION OCCURRING IN THE RIGHT COMMON FEMORAL VEIN, WHICH IN TURN CAUSED BLEEDING FROM THE PATIENT'S RIGHT GROIN. PER FOLLOW-UP, IT WAS NOTED THAT THERE WERE NO COMPLICATIONS REGARDING ACCESS, WHICH WAS GUIDED BY ULTRASOUND. DURING THE PROCEDURE, THE PATIENT REPORTEDLY COUGHED LEADING TO THE DISCOVERY OF A HEMATOMA IN THE RIGHT GROIN. FOLLOWING THE PROCEDURE, TECHNICIANS APPLIED MANUAL PRESSURE FOR A DURATION OF 30 MINUTES IN AN ATTEMPT TO MANAGE THE BLEEDING. A VASCULAR SURGEON WAS CALLED TO ASSIST WHO ADDRESSED THE ACTIVE BLEEDING BY UTILIZING SUTURES. MULTIPLE ACCESS POINTS WERE CREATED IN THE RIGHT FEMORAL VEIN TO EFFECTIVELY HALT THE BLEEDING. AFTER THE PROCEDURE, THE PATIENT WAS PUT ON BED REST FOR FOUR HOURS AND KEPT OVERNIGHT IN THE HOSPITAL TO BE MONITORED. A FOLLOW-UP ULTRASOUND EXAMINATION CONDUCTED ON THE SUBSEQUENT DAY REVEALED THE ABSENCE OF A HEMATOMA OR PSEUDOANEURYSM, THOUGH SOME BRUISING WAS OBSERVED. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE CLINIC.

  Patient problems: Bruise/Contusion; Hematoma; Perforation

  MAUDE report 17638588 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS THE PHYSICIAN REMOVED THE WIRE AND DILATOR, AND WAS GETTING THE SIDE PORT FLUSH CONNECTED, THE PATIENT DESATURATED INTO THE LOW 90S/HIGH 80S AND BECAME HYPOTENSIVE IN THE 90S/60S. REPORTEDLY, THE FLEXCATH AND ACQCROSS WERE ADVANCED TO THE ATRIAL SEPTUM. THE PHYSICIAN TENTED THE SEPTUM, EXTENDED THE ACQCROSS NEEDLE, ADVANCED THE WIRE INTO THE LSPV (LEFT SUPERIOR PULMONARY VEIN), AND RETRACED THE NEEDLE. THEN THE PHYSICIAN ADVANCED THE FLEXCATH AND ACQCROSS TRANSEPTAL INTO THE LEFT ATRIUM, REMOVED THE WIRE AND DILATOR, AND HOOKED UP THE FLEXCATH SIDE PORT TO A HEPARIN FLUSH LINE. AT THE SAME TIME, THE PATIENT'S OXYGEN SATURATIONS DECREASED, AND THE PATIENT BECAME HYPOTENSIVE. THE PHYSICIAN LOOKED ON FLUOROSCOPY FOR PERICARDIAL EFFUSION AND DID NOT SEE ANY AIR MOVING IN THE PATIENT'S THORAX AND LOOKED AGAIN ON INTRACARDIAC ECHOCARDIOGRAPHY(ICE) AND DID NOT SEE ANY EFFUSION. THE ANESTHETIST THEN GAVE A VASOPRESSOR TO ADDRESS THE PATIENT BECOMING HYPOTENSIVE AND THE PHYSICIAN DECIDED TO MOVE FORWARD WITH THE PROCEDURE AND BEGAN PREPPING THE CRYOBALLON. THEN THE PATIENT BEGAN HAVING ST SEGMENT ELEVATION THAT LASTED APPROXIMATELY A MINUTE. THE PHYSICIAN THEN CHECKE

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 17081408 ↗