Diamondback Peripheral DBP-175SOLID180 (REF 7-10057-07)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10850000491233), received between Aug 11, 2021 and Aug 11, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of Device” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS INSERTED INTO A TIGHT, CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE OAD WAS UNABLE TO PASS THROUGH THE LESION DUE TO THE SEVERE CALCIUM, AND ON THE SECOND ATTEMPT THE OAD SOUNDED AS THOUGH IT WAS GOING TO STALL, HOWEVER THE DEVICE CONTINUED TO SPIN. TREATMENT WAS STOPPED, AND THE CROWN WAS STUCK IN THE LESION. THE DEVICE WAS REMOVED WITH SOME EFFORT, AND UPON REMOVAL THE TIP BUSHING WAS MISSING AND THE DRIVESHAFT TIP LOOKED FRAYED. IMAGING REVEALED THERE WAS NO VESSEL DAMAGE. ADDITIONAL REVIEW OF ANGIOGRAPHY COULD NOT LOCATE THE MISSING FRAGMENT, AND AS THE WIRE WAS DISCARDED IT COULD NOT BE CONFIRMED THAT THE FRAGMENT WAS LEFT ON THE WIRE. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12309178 ↗