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Roadrunner G23038Recalls & reported problems

Cook Incorporated · Roadrunner Wire Guide · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002230385), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1
  • Off-Label Use1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryOct 22, 2019Fracture; Off-Label Use; Fracture; Off-Label Use

    DURING A SPHINCTEROTOMY, THE PHYSICIAN USED A COOK ROAD RUNNER WIRE GUIDE. DURING THE SPHINCTEROTOMY A SMALL SEGMENT OF COOK ROADRUNNER GUIDE WIRE WAS FRACTURED AND RETAINED WITHIN THE DORSAL PANCREATIC DUCT. THE SURGEON REPORTS THERE WAS A 'SPARK AND PUFF OF SMOKE' JUST PRIOR TO THE BREAK. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 02-OCT-2019: "A SMALL SEGMENT (THE FLEXIBLE TIP) OF THE GUIDEWIRE WAS FRACTURED AND RETAINED WITHIN THE DORSAL PANCREATIC DUCT. A MULTI-SIZE EXTRACTION BALLOON WAS INSERTED INTO THE DORSAL DUCT AND INFLATED TO THE SMALLEST SIZE ALONGSIDE THE 2 CM SEGMENT OF RETAINED WIRE. THE BALLOON WAS SWEPT THROUGH THE DUCT THREE TIMES WITHOUT SUCCESSFUL RETRIEVAL OF THE WIRE SEGMENT. A CYTOLOGY BRUSH WAS UTILIZED IN A SIMILAR FASHION WITHOUT SUCCESS. FINALLY A COOK SOEHENDRA STENT RETRIEVER WAS UTILIZED TO DILATE THE PROXIMAL PORTION OF THE DORSAL DUCT AND ALSO IN AN ATTEMPT TO RETRIEVE THE GUIDEWIRE SEGMENT UNSUCCESSFULLY. WE WERE HAVING PROBLEMS WITH THE ELECTROSURGICAL GENERATOR. THE SURGEON KEPT TURNING TO HIS RIGHT AND HE THINKS EACH TIME HE TURNED HE WAS ACTUALLY PULLING OUT THE GUIDEWIRE UNTIL THE JUNCTION OF THE HARDWIRE AND THE FLEXIBLE TIP WERE N

    Patient problems: Foreign Body In Patient

    MAUDE report 9218091 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.