GRAND SLAM AG141302JRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
All models of GRAND SLAM (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547327055871), received between Aug 25, 2017 and Jun 10, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Most reported problems
Device problems
- Break2
- Failure to Advance2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Consequences Or Impact To Patient2
- Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2020Break; Failure to Advance
PROXIMAL AND MID RCA LESION. STENT WAS PLACED IN DISTAL LESION. DIFFICULTY GETTING BALLOON TO POST DIL OVER RUN THROUGH. SENT GRAND SLAM DOWN FOR MORE SUPPORT, WOULDN'T ADVANCE SO THEY REMOVED AND NOTICED. THE DISTAL END WAS "BROKEN". SENT SECOND GRAD SLAM DOWN, AGAIN REMOVED WIRE AND DISTAL END BROKEN. NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10141303 ↗MalfunctionJun 10, 2020Break; Failure to Advance
PROXIMAL AND MID RCA LESION. STENT WAS PLACED IN DISTAL LESION. DIFFICULTY GETTING BALLOON TO POST DIL OVER RUN THROUGH. SENT GRAND SLAM DOWN FOR MORE SUPPORT, WOULDN'T ADVANCE SO THEY REMOVED AND NOTICED THE DISTAL END WAS "BROKEN". SENT SECOND GRAD SLAM DOWN, AGAIN REMOVED WIRE AND DISTAL END BROKEN. NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10141210 ↗InjuryAug 25, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SIGNIFICANT STENOSIS, OCCLUSIVE THROMBOEMBOLISM, AND CRITICAL LIMB ISCHEMIA IN THE LEFT DISTAL POPLITEAL ARTERY. A 6FR NON-ABBOTT SHEATH WAS ADVANCED VIA RIGHT COMMON FEMORAL ACCESS, FOLLOWED BY ADVANCE OF AN ANGLED NON-ABBOTT GUIDE WIRE (WITH THE AID OF A NON-ABBOTT CROSSING CATHETER). A 0.014 ASAHI GRAND SLAM GUIDE WIRE WAS THEN ADVANCED TO THE LEFT PERONEAL ARTERY. THROMBECTOMY AND ANGIOPLASTY WERE PERFORMED TO TREAT THE PRE-EXISTING THROMBOEMBOLISM, HOWEVER, THE ANGIOPLASTY RESULTED IN DISTAL EMBOLIZATION OF THROMBUS IN THE POSTERIOR TIBIAL AND PERONEAL ARTERIES; THUS, THROMBECTOMY WAS THEN PERFORMED IN THESE VESSELS. A PERFORATION IN THE LEFT PERONEAL ARTERY WAS THEN NOTED AND WAS UNABLE TO BE SEALED WITH PROLONGED BALLOON INFLATION, AND THE PERIPHERAL VASCULAR STENTS AVAILABLE WERE TOO LARGE TO DEPLOY AT THIS VESSEL SITE. IN THE OPINION OF THE PHYSICIAN, THE PERFORATION WAS LIKELY CAUSED BY A WIRE AND IT IS POSSIBLE THAT USE OF THE GRAND SLAM GUIDE WIRE MAY HAVE CONTRIBUTED TO THIS PERFORATION. THERE WERE NO DEVICE ISSUES WITH THE GRAND SLAM GUIDE WIRE. REPORTEDLY, THE PATIENT WAS ELDERLY, NOT A CANDIDATE FOR SURGICAL REPAIR, AN
Patient problems: Perforation
MAUDE report 6820675 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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