Quick-Cross Support Catheter 518-037 (UDI 00813132020682)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813132020682), received between Oct 3, 2019 and Jul 13, 2021 — classified as 2 injuries, 1 malfunction.

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 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.

• MalfunctionJul 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHILIPS REPRESENTATIVE BECAME AWARE ON 14 JUNE 2021 OF A PERIPHERAL ATHERECTOMY PROCEDURE, PERFORMED (B)(6) 2021 IN WHICH THE PHYSICIAN USED A SPECTRANETICS 2.3 TURBO ELITE LASER ATHERECTOMY CATHETER. ALTHOUGH THE REPRESENTATIVE WAS NOT AT THE PROCEDURE, IT WAS REPORTED THAT TREATMENT OF A STENOSIS OR LESION WAS BEING PERFORMED IN A MODERATELY FIBROUS AREA IN THE POPLITEAL ARTERY. AT THE TIME OF THE 10 MAY PROCEDURE, THERE WERE NO REPORTED ISSUES AND THE PROCEDURE WAS COMPLETED. HOWEVER, AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT''S SYMPTOMS DID NOT RESOLVE AND SO A DUPLEX SCAN WAS PERFORMED. THE SCAN SHOWED "SOMETHING HAD SHUT DOWN", BUT THEY WERE NOT SURE WHAT, SO A SUBSEQUENT PROCEDURE WAS PERFORMED ON 14 JUNE 2021. IN THIS PROCEDURE ON 14 JUNE, THE PHILIPS REPRESENTATIVE WAS PRESENT AT THE PROCEDURE. IT WAS IDENTIFIED THAT THE TURBO ELITE 2.3 DEVICE''S DISTAL MARKER BAND HAD REPORTEDLY DETACHED DURING THE PROCEDURE ON (B)(6) 2021, NOT DISCOVERED AT THAT TIME, AND DURING THE FIRST FLUOROSCOPIC IMAGES TAKEN DURING THE 14 JUNE PROCEDURE, THE MARKER BAND WAS CONFIRMED TO BE PRESENT IN THE PATIENT''S POPLITEAL ARTERY (PLEASE REFERENCE MDR #1721279-2021-00124 WHICH CAPTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163451 ↗
• InjuryNov 4, 2020Break; Break

  IT WAS REPORTED BY A PHILIPS REPRESENTATIVE ON (B)(6) 2020 THAT AN EVENT OCCURRED ON (B)(6) 2020 IN WHICH A SPECTRANETICS QUICK-CROSS SUPPORT CATHETER WAS BEING USED. IT WAS REPORTED ON (B)(6) 2020 BY THE FACILITY THAT THE PROCEDURE WAS A LEFT LOWER EXTREMITY ANGIOGRAM AND BALLOON ANGIOPLASTY. IT WAS REPORTED THAT THE DISTAL SEGMENT OF THE QUICK-CROSS CATHETER HAD BROKEN OFF IN THE PATIENT'S LEFT ILIAC ARTERY. IT WAS REPORTED THAT THERE WAS AN ATTEMPT TO RETRIEVE THE DEVICE PORTION; HOWEVER THE SURGEON REPORTED THAT THIS QUICK-CROSS DISTAL SEGMENT OF CATHETER WAS LEFT IN PLACE WITHIN THE PATIENT. THE PATIENT REPORTEDLY SURVIVED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE FROM THE FACILITY, ALTHOUGH IT HAS BEEN REQUESTED.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 10785876 ↗
• InjuryOct 3, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2019 FROM THE REP REGARDING THE EVENT: CLARIFICATION PROVIDED THAT THE IM ARTERY WAS THE INFERIOR MESENTERIC ARTERY. THE ARTERY WAS EXTENSIVELY CALCIFIED AT THE ENTRY POINT. THE QUICK-CROSS CATHETER GOT CAUGHT ON THE CALCIUM AT THE ORIGIN OF THE ARTERY. THE CATHETER TIP BROKE OFF BEFORE A STENT WAS PLACED.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 9153759 ↗