GRAND SLAM AG141002Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04547327055833), received between Jul 1, 2019 and Feb 9, 2025 — classified as 2 deaths, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PERCUTANEOUS CORONARY INTERVENTION TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND HEAVILY FLEXUOUS LESION IN THE MID LEFT CIRCUMFLEX ARTERY (LCX). TWO UNITS OF ASAHI GRAND SLAM GUIDE WIRES, TOGETHER WITH A GUIDEZILLA MICROCATHETER (BOSTON SCIENTIFIC) AND AN UNSPECIFIED 8FR EBU GUIDING CATHETER WERE USED TO DEPLOY AN UNSPECIFIED STENT SYSTEM IN THE HEAVILY CALCIFIED LESION BUT TENSION AND RESISTANCE WERE MET. WHEN ATTEMPTS WERE MADE TO PULL BACK THE STENT UNITS FOR REPOSITION, THE STENTS DISLODGED FROM THE STENT SYSTEM, CAUSING THE TWO GRAND SLAM GUIDE WIRES TO BREAK OFF AND LEAVING THE WIRE FRAGMENTS IN THE LCX. THE PHYSICIAN THEN CAPTURED THE STENTS AND THE WIRE FRAGMENTS WERE STENTED TO COMPLETE THE PROCEDURE. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21340839 ↗
• InjuryFeb 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PERCUTANEOUS CORONARY INTERVENTION TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND HEAVILY FLEXUOUS LESION IN THE MID LEFT CIRCUMFLEX ARTERY (LCX). TWO UNITS OF ASAHI GRAND SLAM GUIDE WIRES, TOGETHER WITH A GUIDEZILLA MICROCATHETER (BOSTON SCIENTIFIC) AND AN UNSPECIFIED 8FR EBU GUIDING CATHETER WERE USED TO DEPLOY AN UNSPECIFIED STENT SYSTEM IN THE HEAVILY CALCIFIED LESION BUT TENSION AND RESISTANCE WERE MET. WHEN ATTEMPTS WERE MADE TO PULL BACK THE STENT UNITS FOR REPOSITION, THE STENTS DISLODGED FROM THE STENT SYSTEM, CAUSING THE TWO GRAND SLAM GUIDE WIRES TO BREAK OFF AND LEAVING THE WIRE FRAGMENTS IN THE LCX. THE PHYSICIAN THEN CAPTURED THE STENTS AND THE WIRE FRAGMENTS WERE STENTED TO COMPLETE THE PROCEDURE. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21320013 ↗
• MalfunctionJan 31, 2025Break; Break

  DR. (B)(6) WAS ATTEMPTING TO ADVANCE THE STENT INTO A HEAVY CALCIFIED CIRCUMFLEX CORONARY ARTERY THROUGH AN 8F EBU WITH 2 ASAHI GRAND SLAM WIRES AND A GUIDZILLA MICRO CATH. THE CURVATURE WAS ACUTE. THERE WAS TENSION AND RESISTANCE, THEREFORE, WHEN DR. (B)(6) ATTEMPTED TO PULL THE STENTS BACK AND REPOSITION, THE STENTS DISLODGED FROM THE STENT SYSTEM, RESULTING BOTH WIRES BROKE OFF INTO THE LCX CORONARY ARTERY. HE CAPTURED THE STENT AND STENTED THE TWO PIECES OF GRAND SLAM WIRES IN PLACE. THE CASE WAS FINISHED, AND NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289019 ↗
• InjuryJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING COIL OF AN ASAHI GRAND SLAM GUIDE WIRE HAD FRACTURED AND THE TIP OF AN ASAHI GLADIUS MONGO 14 GUIDE WIRE BROKE OFF DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A >20MM LONG, HEAVILY CALCIFIED, CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) INCLUDING THE OSTIUM. THE GRAND SLAM WAS ADVANCED INTO A NON-ASAHI TURNPIKE SPIRAL MICROCATHETER IN AN ATTEMPT TO BASE AT THE PROXIMAL CAP OF THE CTO. IT WAS BELIEVED THAT THE TIP OF GRAND SLAM GOT CAUGHT IN THE CALCIUM AND STRIPPED OFF THE SPRING COIL. THE SPRING COIL WAS LEFT IN THE RCA CTO. GLADIUS MONGO 14 WAS LATER USED TO KNUCKLE THROUGH THE PROXIMAL CAP THAT WAS ALREADY BASED. HOWEVER, GLADIUS MONGO 14 WOULD NOT KNUCKLE AND USED AS PENETRATION WIRE UNTIL WIRE WAS EMBEDDED INTO CALCIFIED LESION. NO ATTEMPTS WERE MADE TO RETRIEVE BOTH WIRE TIPS AS THEY WERE IN THE SUBINTIMAL SPACE AND IN THE HEAVILY CALCIFIED CTO SEGMENT THAT WAS UNSUCCESSFULLY ATTEMPTED. BOTH ANTEGRADE AND RETROGRADE APPROACHES WERE MADE; HOWEVER, THE PROCEDURE WAS UNSUCCESSFULLY COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITHOUT ADVERSE EFFECTS. GLADIUS MONGO 14 IS

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17222700 ↗
• MalfunctionJun 27, 2023Material Fragmentation; Material Fragmentation

  GRAND SLAM WAS ADVANCED INTO THE TURNPIKE SPIRAL. IT IS BELIEVED THAT THE GRAND SLAM GOT CAUGHT IN THE CALCIUM AND STRIPPED OFF THE SPRING COIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 17211016 ↗
• InjuryJul 8, 2021Break

  GRAND SLAM WIRE AT (B)(6) CCL CASE WITH DR. (B)(6) HAD TO RETRIEVE THE GRAND SLAM WIRE @ IT BROKE OFF IN PATIENT. VEIN CALCIFIED 80% STARTED WITH A BMW WIRE AND CHANGED OUT TO THE GRAND SLAM FOR EASIER PLACEMENT . WHILE ADVANCING GRAND SLAM WIRE, THE WIRE BROKE OFF ABOUT AT THE MIDWAY PORTION OF THE WIRE. BOTH PORTIONS OF THE WIRE WERE REMOVED. THE BROKEN WIRE HAD TO BE SNARED AND REMOVED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 12140439 ↗
• DeathJun 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DESCRIPTION OF WHAT OCCURRED INTRA-PROCEDURALLY, FOUND HIGH-GRADE DISTAL LEFT MAIN INTO OSTIAL LCX STENOSIS, TREATED WITH ROTATIONAL ATHERECTOMY, PCI AND STENT OF THE LEFT MAIN INTO LCX. AN ASAHI GRAND SLAM GUIDE WIRE WAS PROLAPSED IN THE DISTAL OM. AT END OF PROCEDURE, WHEN IT WAS REMOVED, THE PROLAPSED SEGMENT WAS NOT ATTACHED TO THE WIRE. NO RESISTANCE WAS FELT. COMPLICATED BY WIRE PERFORATION AND SMALL PERICARDIAL EFFUSION, TREATED WITH BALLOON TAMPONADE. WHILE BALLOON WAS UP, PATIENT BECAME HYPOTENSIVE AND EVENTUALLY PEA ARREST REQUIRING CHEST COMPRESSIONS. PERICARDIAL DRAIN PLACED EMPIRICALLY WITHOUT IMPROVEMENT, THEN IMPELLA PLACED BUT THERE WAS DIFFICULTY INSERTING IMPELLA DUE TO SEVERE ILIAC DISEASE, TREATED WITH BALLOON ANGIOPLASTY AND EVENTUAL IMPELLA PLACEMENT, HOWEVER DURING THIS TIME HAD VF REFRACTORY TO SHOCK. ANOTHER DRAIN WAS PLACED DURING ROUNDS OF CPR BUT WAS ACTUALLY PLACED IN LV. ACCESS OF R FEMORAL WAS NOT POSSIBLE DUE TO CHRONIC OCCLUSION, SO R BRACHIAL ACCESS OBTAINED. ANGIOGRAPHY REVEALED THROMBOSED LEFT MAIN, OPENED INTO LAD BUT COULD NOT OPEN LCX. TEMP PACER PLACED DUE TO INTERMITTENT SINUS WITH BLOCK/VT/VF. AFTER DISCUSSION WITH FAMILY, DECIDED TO WITHDR

  Patient problems: Perforation of Vessels

  MAUDE report 12047773 ↗
• DeathJun 4, 2021Material Perforation

  DESCRIPTION OF WHAT OCCURRED INTRA-PROCEDURALLY, FOUND HIGH-GRADE DISTAL LEFT MAIN INTO OSTIAL LCX STENOSIS, TREATED WITH ROTATIONAL ATHERECTOMY, PCI AND STENT OF THE LEFT MAIN INTO LCX. COMPLICATED BY WIRE PERFORATION AND SMALL PERICARDIAL EFFUSION, TREATED WITH BALLOON TAMPONADE. WHILE BALLOON WAS UP, PATIENT BECAME HYPOTENSIVE AND EVENTUALLY PEA ARREST REQUIRING CHEST COMPRESSIONS. PERICARDIAL DRAIN PLACED EMPIRICALLY WITHOUT IMPROVEMENT, THEN IMPELLA PLACED BUT THERE WAS DIFFICULTY INSERTING IMPELLA DUE TO SEVERE ILIAC DISEASE, TREATED WITH BALLOON ANGIOPLASTY AND EVENTUAL IMPELLA PLACEMENT, HOWEVER DURING THIS TIME HAD VF REFRACTORY TO SHOCK. ANOTHER DRAIN WAS PLACED DURING ROUNDS OF CPR BUT WAS ACTUALLY PLACED IN LV. ACCESS OF R FEMORAL WAS NOT POSSIBLE DUE TO CHRONIC OCCLUSION, SO R BRACHIAL ACCESS OBTAINED. ANGIOGRAPHY REVEALED THROMBOSED LEFT MAIN, OPENED INTO LAD BUT COULD NOT OPEN LCX. TEMP PACER PLACED DUE TO INTERMITTENT SINUS WITH BLOCK/VT/VF. AFTER DISCUSSION WITH FAMILY, DECIDED TO WITHDRAW CARE. PERFORMED ROTATIONAL ATHERECTOMY OF THE LEFT MAIN INTO THE LCX WITH ROTA FLOPPY WIRE IN THE OM1. ROTABLATOR REMOVED AND WIRE EXCHANGED OVER CORSAIR FOR GRAND SLAM. MULTIPLE

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Pericardial Effusion; Stenosis; Thrombosis/Thrombus

  MAUDE report 11940201 ↗
• InjuryJul 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GRAND SLAM GUIDE WIRE WAS BEING INTRODUCED TO THE PATIENT BODY THROUGH A GUIDELINER CATHETER AND BECAME PROLAPSED IN THE GUIDELINER BUT NEVER MADE IT TO THE VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO PULL IT BACK OUT TO OPEN THE PROLAPSE, THE WIRE BECAME ENTANGLED IN THE GUIDELINER AND SUBSEQUENTLY UNRAVELED. THE GRAND SLAM WAS SUCCESSFULLY REMOVED AND ANOTHER WIRE WAS PLACED IN THE VESSEL TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS RELATED TO THE UNRAVELED GUIDE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824780 ↗
• InjuryJul 19, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY TORTUOUS AND NON-CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A NON-ABBOTT GUIDE WIRE WAS RETRACTED AFTER AN UNSPECIFIED STENT WAS DEPLOYED. ALTHOUGH THERE WAS NO RESISTANCE DURING REMOVAL, THE RADIOPAQUE PORTION OF THE GUIDE WIRE BECAME DETACHED. IT IS UNKNOWN WHY THE GUIDE WIRE DETACHED. THE DETACHED PORTION OF THE GUIDE WIRE WAS LOCATED OUTSIDE THE UNSPECIFIED STENT. A 190 CM BALANCE MIDDLE WEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS ADVANCED TO RETRIEVE THE SEPARATED NON-ABBOTT GUIDE WIRE. THE PHYSICIAN INTENTIONALLY CAUSED THE BMW GUIDE WIRE TO BECOME ENTANGLED WITH THE DETACHED NON-ABBOTT GUIDE WIRE. BOTH GUIDE WIRES WERE PULLED BACK TOGETHER THROUGH THE PREVIOUSLY DEPLOYED UNSPECIFIED STENT; HOWEVER, THE GUIDE WIRES BECAME STUCK INSIDE THE UNSPECIFIED STENT. THE DISTAL PORTION OF THE BMW GUIDE WIRE BECAME DETACHED. A SECOND UNSPECIFIED STENT WAS DEPLOYED TO CRUSH BOTH DETACHED GUIDE WIRES AGAINST THE VESSEL. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT IS STABLE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8807897 ↗
• MalfunctionJul 17, 2019Unraveled Material; Material Twisted/Bent

  GRAND SLAM WAS BEING INTRODUCED TO BODY THROUGH A GUIDELINER AND BECAME PROLAPSED IN THE GUIDELINER BUT NEVER MADE IT TO THE VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO PULL IT BACK OUT TO OPEN THE PROLAPSE, THE WIRE BECAME ENTANGLED IN THE GUIDELINER AND SUBSEQUENTLY UNRAVELED.

  Patient problems: Prolapse

  MAUDE report 8800714 ↗
• InjuryJul 1, 2019Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY TORTUOUS AND NON-CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. AN ASAHI GUIDE WIRE WAS RETRACTED AFTER AN UNSPECIFIED STENT WAS DEPLOYED. ALTHOUGH THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL, THE RADIOPAQUE PORTION OF THE GUIDE WIRE BECAME DETACHED. IT IS UNKNOWN WHY THE GUIDE WIRE DETACHED. THE DETACHED PORTION OF THE GUIDE WIRE WAS LOCATED OUTSIDE THE UNSPECIFIED STENT. A 190 CM NON-ASAHI GUIDE WIRE WAS ADVANCED TO RETRIEVE THE SEPARATED ASAHI GUIDE WIRE. THE PHYSICIAN INTENTIONALLY CAUSED THE NON-ASAHI GUIDE WIRE TO BECOME ENTANGLED WITH THE DETACHED ASAHI GUIDE WIRE. BOTH GUIDE WIRES WERE PULLED BACK TOGETHER THROUGH THE PREVIOUSLY DEPLOYED UNSPECIFIED STENT; HOWEVER, THE GUIDE WIRES BECAME STUCK INSIDE THE UNSPECIFIED STENT. THE DISTAL PORTION OF THE NON-ASAHI GUIDE WIRE BECAME DETACHED. A SECOND UNSPECIFIED STENT WAS DEPLOYED TO CRUSH BOTH DETACHED GUIDE WIRES AGAINST THE VESSEL. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT IS STABLE. NO DAMAGE TO THE PREVIOUSLY DEPLOYED STENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO AD

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8751545 ↗