GRAND SLAM AG141302Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04547327055857), received between Sep 29, 2017 and Jan 8, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026

  FROM STAFF: OPENED A 300CM .014 GRAND SLAM WIRE TO THE FIELD. WHEN THE SURGEON WAS USING THE WIRE, WE NOTICED A DEFECT IN THE WIRE UNDER XRAY. THE SURGEON REMOVED THE WIRE FROM THE PATIENT, AND WE OPENED A NEW WIRE. FROM OPERATIVE REPORT: TWO PROGLIDE DEVICES WERE DEPLOYED IN THE STANDARD FASHION FOR LARGE-BORE ACCESS CLOSURE. ONE FAILED AND A 3RD DEVICE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002745 ↗
• InjuryOct 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI GRAND SLAM GUIDE WIRE WAS USED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) TO TREAT A HEAVILY CALCIFIED LESION IN THE PROXIMAL TIBIAL ARTERY. AS THE GRAND SLAM GUIDE WIRE WAS CAUGHT BY THE CALCIUM AND FRACTURED, AN UNSPECIFIED SNARE WAS USED TO SUCCESSFULLY REMOVE THE FRAGMENT. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20554053 ↗
• MalfunctionOct 14, 2024Calcified; Entrapment of Device; Fracture; Calcified; Entrapment of Device; Fracture

  GRAND SLAM WAS LOCKED IN CALCIUM AND REMOVED. NO PATIENT INJURY. THE WIRE WAS SNARED AND REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440315 ↗
• MalfunctionMay 16, 2023Break; Break

  I WAS IN A CASE TODAY WHERE A GRANDSLAM 300CM WIRE WAS USED AND WE NOTICED IMMEDIATELY THAT THE END OF THE WIRE APPEARED TO BE BROKEN OR FRACTURED. THERE WAS A GAP IN THE RADIOPAQUE BAND. THE WIRE WAS INTRODUCED THROUGH A CORSAIR PRO XS 150. THE WIRE WAS REMOVED INTACT, AND I HAVE THE WIRE TO SEND IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16941974 ↗
• InjuryApr 10, 2018Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED AND TORTUOUS ILIAC ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE WAS PLACED FOR DISTAL PROTECTION. THE GRAND SLAM GUIDE WIRE WAS PLACED SUBINTIMALLY. DURING USE OF A NON-ABBOTT REENTRY DEVICE, THE REENTRY DEVICE NEEDLE PIERCED THE GUIDE WIRE AND SHEARED OFF A PORTION OF THE GUIDE WIRE. THE SEPARATED GUIDE WIRE PORTION REMAINS IN THE PATIENT ANATOMY. NO ATTEMPT WAS MADE TO REMOVE THE SEPARATED GUIDE WIRE SEGMENT. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE FILTER WAS PULLED INTO THE RETRIEVAL CATHETER WITHOUT DIFFICULTY; HOWEVER, DURING REMOVAL, THE RETRIEVAL CATHETER KINKED AND WAS DIFFICULT TO REMOVE FROM THE NON-ABBOTT INTRODUCER SHEATH. THE INTRODUCER SHEATH AND RETRIEVAL CATHETER WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT WITH REGARDS TO THE EMBOSHIELD NAV6. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7420088 ↗
• MalfunctionDec 18, 2017Difficult To Position; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL VESSEL WITH NO CALCIFICATION OR TORTUOSITY. THE FIRST GRANDSLAM GUIDE WIRE WAS ADVANCED THROUGH AN UN-SPECIFIED BALLOON DILATATION CATHETER (BDC); HOWEVER, RESISTANCE WAS NOTED. THE GUIDE WIRE WAS RETRACTED, BUT RESISTANCE WAS MET WITH THE BDC; THEREFORE, THE GUIDE WIRE AND BDC WERE REMOVED TOGETHER. OUTSIDE THE ANATOMY, THE DEVICES WERE SEPARATED SUCCESSFULLY. A NEW GRANDSLAM GUIDE WIRE WAS USED WITH THE SAME BDC; HOWEVER, THE SAME ISSUE OCCURRED. THE DEVICES WERE REMOVED AND A NEW GRANDSLAM GUIDE WIRE WAS USED WITH THE SAME BDC SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127704 ↗
• MalfunctionDec 18, 2017Difficult To Position; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL VESSEL WITH NO CALCIFICATION OR TORTUOSITY. THE FIRST GRANDSLAM GUIDE WIRE WAS ADVANCED THROUGH AN UN-SPECIFIED BALLOON DILATATION CATHETER (BDC); HOWEVER, RESISTANCE WAS NOTED. THE GUIDE WIRE WAS RETRACTED, BUT RESISTANCE WAS MET WITH THE BDC; THEREFORE, THE GUIDE WIRE AND BDC WERE REMOVED TOGETHER. OUTSIDE THE ANATOMY, THE DEVICES WERE SEPARATED SUCCESSFULLY. A NEW GRANDSLAM GUIDE WIRE WAS USED WITH THE SAME BDC; HOWEVER, THE SAME ISSUE OCCURRED. THE DEVICES WERE REMOVED AND A NEW GRANDSLAM GUIDE WIRE WAS USED WITH THE SAME BDC SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127653 ↗
• InjurySep 29, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE LOWER EXTREMITY. AN ATHERECTOMY DEVICE WAS ADVANCED OVER AN ASAHI GRANDSLAM GUIDE WIRE; HOWEVER, THE GUIDE WIRE SEPARATED. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE SEPARATED PORTION OF THE GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6904143 ↗