Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter M5PIVL7060Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00195451000270), received between Nov 4, 2022 and Mar 11, 2026 — classified as 1 death, 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT AN UNSPECIFIED LESION. IT WAS REPORTED THAT TWO HUNDRED AND SEVENTY PULSES (270) WERE DELIVERED. DURING THE TENTH TREATMENT CYCLE, THE SHOCKWAVE BALLOON RUPTURED AND WOULD NOT DEFLATE. UPON REMOVAL ATTEMPT, THE BALLOON'S SHEATH BECAME LODGED AND COULD NOT BE WITHDRAWN FROM THE 7F INTRODUCER. THE SHAFT BROKE WHEN THE SURGEON PULLED ON THE SHAFT TO REMOVE THE STUCK BALLOON. THE PHYSICIAN HAD TO CUT THE GUIDE CATHETER TO REMOVE THE INTRODUCER WITH THE BALLOON STILL INSIDE, WHICH PROLONGED THE PROCEDURE FOR THE PATIENT. THE PHYSICIAN REPLACED THE INTRODUCER AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT HARM WAS REPORTED FOR THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565877 ↗
• MalfunctionJan 30, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA)/POPLITEAL. 180 IVL PULSES WERE DELIVERED. DURING THE BALLOON REMOVAL ATTEMPT, THE BALLOON WOULD NOT PASS THROUGH THE SHEATH AND DETACHED FROM THE IVL CATHETER. THE BALLOON SEPARATED INSIDE THE PATIENT AFTER EXCESSIVE FORCE WAS APPLIED DURING REMOVAL ATTEMPTS. A SECOND ACCESS SITE WAS REQUIRED, AND THE DETACHED BALLOON WAS SUBSEQUENTLY RETRIEVED WITH A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223187 ↗
• MalfunctionJan 2, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED DURING A PROCEDURE TO TREAT LESIONS IN BOTH ILIAC ARTERIES. THE SURGEON USED A 7.0MM M5+ CATHETER TO PERFORM IVL ON BOTH ILIAC ARTERIES VIA AN UP-AND-OVER APPROACH OVER A BOSTON SCIENTIFIC 0.014" THRUWAY WIRE, DELIVERING A TOTAL OF 170 PULSES ACROSS BOTH ILIACS (LEFT EXTERNAL AND COMMON, AND RIGHT COMMON). FOLLOWING DEFLATION OF THE BALLOON, THE IVL CATHETER WAS ATTEMPTED TO BE REMOVED AND BECAME STUCK. THE SURGEON APPLIED INCREASED TRACTION AND NEARLY ALL OF THE DEVICE WAS RETRIEVED, BUT THE BALLOON PORTION REMAINED INSIDE THE PATIENT, EVIDENCED BY THE BALLOON MARKERS. MULTIPLE ATTEMPTS TO SNARE AND RETRIEVE THE RETAINED PORTION USING TWO EN SNARE DEVICES WERE UNSUCCESSFUL. MULTIPLE VIABAHN STENTS WERE PLACED IN THE AORTA AND BILATERAL ILIACS, FOLLOWED BY BALLOON ANGIOPLASTY TO TREAT THE DISEASE AND PIN THE RETAINED PORTION OF THE BALLOON AGAINST THE VESSEL WALL. THERE WAS NO REPORT OF ANY PATIENT HARM THAT OCCURRED. THE PATIENT DID WELL, STAYED OVERNIGHT, AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23951802 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT AN ILIAC LESION. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE PULSING AND DETACHED FROM THE CATHETER. ADDITIONAL INFORMATION INDICATED THAT THE DETACHMENT OCCURRED AFTER TREATMENT WHEN EXCESSIVE FORCE WAS USED TO REMOVE THE BALLOON DUE TO RESISTANCE IN THE SHEATH. THE BALLOON WAS FULLY DEFLATED BEFORE REMOVAL AND THE REMAINING FRAGMENT WAS COVERED WITH A STENT. THE PHYSICIAN BELIEVED THE BALLOON RUPTURED DURING PULSING, CAUSING FRAGMENTATION. NO ADDITIONAL DETAILS RELATED TO PATIENT DEMOGRAPHICS OR MEDICAL HISTORY ARE AVAILABLE. THE WAS NO PATIENT HARM RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749835 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT LESIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY, SUCCESSFULLY DELIVERING 300 PULSES. DURING REMOVAL OF THE IVL CATHETER, THE DISTAL PORTION OF THE BALLOON BECAME STUCK IN THE INTRODUCER SHEATH, AND APPROXIMATELY 10 CM OF THE CATHETER SHAFT BROKE, LEAVING THE BALLOON FRAGMENT INSIDE THE INTRODUCER. IT WAS NOTED THAT NO EXCESSIVE FORCE WAS APPLIED, AND THE BALLOON WAS FULLY DEFLATED UPON ATTEMPTS TO REMOVE. THE DETACHED PORTION WAS SUCCESSFULLY RETRIEVED BY REMOVING THE PIECE TOGETHER WITH THE INTRODUCER. NO FURTHER INTERVENTIONS WERE REQUIRED, AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300025 ↗
• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS BEING USED TO TREAT AN ILIAC LESION. THE PHYSICIAN WAS TREATING THE RIGHT ILIAC LESION WHICH WAS ACCESSED THROUGH THE RIGHT FORMAL ARTERY USING THE IVL WHEN THE DISTAL PORTION OF THE BALLOON DETACHED DURING AN ADJUSTMENT OF THE CATHETERS POSITION WITHIN THE ARTERY. THE PROXIMAL PORTION OF THE CATHETER AND BALLOON WERE SUCCESSFULLY RETRIEVED WITH ISSUE, WHILE THE DISTAL BALLOON PORTION REMAINED ON THE .014" GUIDEWIRE, WAS REMOVED USING A SNARE. THE NUMBER OF PULSES DELIVERED BEFORE THE DETACHMENT IS UNKNOWN. THE PHYSICIAN NOTED THAT THERE WAS NO RESISTANCE DURING THE INITIAL ADVANCEMENT OR ADJUSTMENT OF THE CATHETER WITHIN THE ARTERY. THE PROCEDURE WAS COMPLETED USING A STANDARD PERIPHERAL ANGIOPLASTY BALLOON. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465893 ↗
• DeathSep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES PRIOR TO PLACING A 26 AORTIC VALVE. THE PHYSICIAN CHOSE THE M5+ 7.0 MM IVL CATHETER BASED ON DISEASE PROCESS, VESSEL SIZE, AND DIAMETER NEEDED TO ADVANCE THE AORTIC VALVE. THE LENGTH OF THE COMMON ILIAC AND EXTERNAL ILIAC ARTERIES WERE TREATED WITH ALL 300 PULSES OF THE IVL DEVICE. THE PHYSICIAN ADVANCED THE 16F DILATOR WITHOUT RESISTANCE, BUT MET RESISTANCE WHEN ATTEMPTING TO ADVANCE THE 18F DELIVERY SHEATH. THE PHYSICIAN ASKED FOR AN L6 8.0 MM IVL CATHETER; HOWEVER, WHILE THE L6 DEVICE WAS BEING OPENED AND PREPPED, THE PHYSICIAN MADE A SECOND ATTEMPT TO CROSS THE LESION WITH THE 18F SHEATH, AND THE SHEATH ADVANCED. AT THAT POINT, THE PHYSICIAN MADE THE DECISION NOT TO TREAT THE VESSEL ANY FURTHER AND TO PROCEED WITH THE INSERTION AND PLACEMENT OF THE VALVE. AS THE PHYSICIAN WAS ADVANCING THE VALVE THROUGH THE SHEATH, THE VALVE GOT STUCK NEAR THE AREA OF STENOSIS WITHIN THE SHEATH. THERE WAS DIFFICULTY ADVANCING OR REMOVING THE VALVE AS THE SHEATH HAD EXPANDED AND BECAME STUCK IN THE ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH, AND THE PATIENT EXPERIENCED A

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 20242046 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A SHOCKWAVE PERIPHERAL M5+ INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERIES. DURING THE PROCEDURE, THE SHAFT OF THE CATHETER KINKED AND BROKE. THERE WAS A COMPLETE SEPARATION. 3 EMITTERS ALONG WITH THE BALLOON MATERIAL WERE LODGED IN THE PATIENT'S COMMON ILIAC ARTERY (CIA). A COVERED STENT WAS PLACED TO PIN AND CONTAIN THE BALLOON AND THE 3 EMITTERS. THE PHYSICIAN WAS ABLE TO MANUALLY REMOVE THE EMITTERS FROM THE ARTERY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041788 ↗
• MalfunctionApr 23, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE COMMON AND EXTERNAL ILIAC ARTERIES. DURING REMOVAL OF THE CATHETER, THE BALLOON HUNG ONTO THE 6 FR TERUMO SHEATH. THERE WAS EXCESSIVE FORCE PUT ON THE CATHETER RESULTING IN THE DISTAL MARKER BAND ALONG WITH THE BALLOON ITSELF TO REMAIN IN THE BODY. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE OUT THE REMAINING PORTION OF THE BALLOON. THEY THEN WERE ABLE TO ADVANCE A WIRE PAST THE BALLOON LEFT IN THE ARTERIOTOMY AND A COVERED STENT WAS IMPLANTED TO PUSH THE DETACHED COMPONENT TO THE VESSEL WALL TO ESTABLISH BRISK FLOW BACK TO THE ILIAC. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165385 ↗
• MalfunctionMar 5, 2024Material Puncture/Hole; Material Rupture; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Puncture/Hole; Material Rupture; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  A SHOCKWAVE M5 PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN THE EXTERNAL ILIAC ARTERY (EIA). THE IVL BALLOON SUCCESSFULLY DELIVERED 210 PULSES. HOWEVER, A BALLOON LOSS OF PRESSURE SUBSEQUENTLY OCCURRED. THE PHYSICIAN REMOVED THE CATHETER, AND IT WAS OBSERVED THAT THE DISTAL END OF THE BALLOON TIP WAS MISSING. THE TIP WAS IDENTIFIED VIA FLUOROSCOPY THAT IT WAS IN THE EIA. THE PHYSICIAN DECIDED TO LEAVE THE TIP IN PLACE AND DEPLOY A SELF-EXPANDING STENT GRAFT TO COVER THE AREA-AS ORIGINALLY PLANNED PRIOR TO THE PROCEDURE. TO DATE, NO PATIENT SEQUELAE HAS OCCURRED AS A RESULT OF THE DETACHMENT OF CATHETER COMPONENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842280 ↗
• MalfunctionJan 25, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHOCKWAVE IVL (INTRAVASCULAR LITHOTRIPSY) M5+ PERIPHERAL CATHETER WAS USED TO TREAT A LESION IN THE ILIAC ARTERY. AFTER TREATMENT, THERE WAS DIFFICULTY REMOVING THE BALLOON FROM THE 7FR SHEATH. A DETACHMENT OCCURRED ALMOST ALL THE WAY BACK IN THE SHEATH. APPROXIMATELY HALF OF THE BALLOON WAS SEPARATED FROM THE PROXIMAL BALLOON MARKER TO ABOUT THE THIRD EMITTER. THE BALLOON MATERIAL WAS HANGING OFF THE DISTAL EDGE OF THE BALLOON, BUT NOT COMPLETELY SEPARATED. THE PHYSICIAN WAS ABLE TO GET ALL OF THE BALLOON MATERIAL OUT OF THE PATIENT. THE PHYSICIAN REMOVED THE SHEATH AND THE IVL BALLOON WHILE MAINTAINING THE WIRE POSITION AND A NEW SHEATH WAS INSERTED. THERE WAS DIFFICULTY REMOVING THE BALLOON OFF THE WIRE ONCE IT WAS OUTSIDE THE BODY. THE PHYSICIAN CLAMPED A HEMOSTAT TO THE BALLOON SHAFT TO REMOVE THE IVL CATHETER AND PULLED WHILE THE TECH HELD THE WIRE IN POSITION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580978 ↗
• MalfunctionDec 14, 2023Material Puncture/Hole; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Puncture/Hole; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn

  AN M5+ IVL PERIPHERAL CATHETER WAS BEING UTILIZED TO TREAT THE ILIAC ARTERY. A BALLOON LOSS OF PRESSURE WAS ENCOUNTERED AFTER 90 PULSES HAD BEEN SUCCESSFULLY ADMINISTERED. AS THE PHYSICIAN WAS WITHDRAWING THE IVL CATHETER, THE BALLOON BECAME DETACHED FROM THE CATHETER SHAFT. THE DETACHED PORTION OF THE IVL CATHETER WAS SUCCESSFULLY REMOVE VIA SNARING. TO DATE, NO PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331070 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN M5PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON CATHETER SUCCESSFULLY DELIVERED 120 PULSES IN THE ILIAC ARTERY. HOWEVER, AFTER ANGIOGRAM WAS PERFORMED, IT WAS NOTED THAT SOME DISTAL EMBOLI WAS OBSERVED IN THE POSTERIOR TIBIAL ARTERY. THE PHYSICIAN ASPIRATED THE EMBOLI USING THE PENUMBRA'S INDIGO ® ASPIRATION SYSTEM. IT WAS REPORTED THAT THERE WAS NOTHING HARD IN THE CHAMBER AND MOST LIKELY THE EMBOLIZATION WAS A THIN MATERIAL. THE IVL TREATMENT ACHIEVED GOOD RESULTS. THERE WAS NO REPORT OF IVL CATHETER MALFUNCTION. IT WAS MENTIONED THAT THE ARTERIES HAD RING STRIPPING, A FORM OF INTERVENTION MANY YEARS AGO SO THE INTIMA AND MEDIA WERE VERY FRAGILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080499 ↗
• MalfunctionOct 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN USED THE SHOCKWAVE M5PLUS PERIPHERAL LITHOTRIPSY INTRAVASCULAR (IVL) CATHETER TO TREAT A LESION IN THE ILIAC REGION. WHILE ATTEMPTING TO ADVANCE THE CATHETER TOWARDS THE LESION, THE PHYSICIAN ENCOUNTERED DIFFICULTY. IN AN ATTEMPT TO RESOLVE THE ISSUE, THE PHYSICIAN DECIDED TO RETRACT THE CATHETER. HOWEVER, THE DISTAL END OF THE BALLOON BROKE OFF, BUT REMAINED ATTACHED TO THE GUIDEWIRE. THE REPORTED BREAK OCCURRED AT ABOUT 20MM FROM THE TIP OF THE BALLOON. THE REP CONFIRMED THAT BALLOON FRAGMENT WAS STILL ON THE GUIDEWIRE, AND IT DID NOT FALL INSIDE THE PATIENT. THE PHYSICIAN DECIDED TO INSERT A NEW SHEATH AND OPTED FOR CONTRALATERAL FEMORAL ACCESS. THEN THE GUIDEWIRE WAS ADVANCED WITH THE BROKEN BALLOON STILL ATTACHED TO THE NEWLY PLACED SHEATH. FINALLY, THE PHYSICIAN SUCCESSFULLY REMOVED THE BROKEN IVL BALLOON AND GUIDEWIRE FROM THE NEWLY ACCESSED SHEATH WITHOUT CAUSING ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876092 ↗
• MalfunctionJun 12, 2023Material Fragmentation; Difficult to Remove; Material Separation; Detachment of Device or Device Component; Material Fragmentation; Difficult to Remove; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION LOCATED IN THE COMMON FEMORAL ARTERY (CFA). THE FIRST IVL BALLOON RUPTURED AFTER 3 CYCLES SO A SECOND IVL BALLOON WAS PREPPED AND USED. THE BALLOON SUCCESSFULLY DELIVERED ALL 300 PULSES IN THE CFA AND THEN THE BALLOON WAS REPOSITIONED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO DELIVER AN ADDITIONAL 75 PULSES. DURING POST DILATATION, THE BALLOON RUPTURED AND WHEN THE PHYSICIAN WAS REMOVING THE CATHETER, DIFFICULTIES REMOVING THE CATHETER THOUGH A 6F SHEATH WAS ENCOUNTERED. ONCE THE CATHETER WAS OUTSIDE THE PATIENT'S ANATOMY, IT WAS OBSERVED THAT THE DISTAL 20-30MM OF THE BALLOON MATERIAL WAS MISSING. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO LOCATE THE MISSING PIECE OF THE BALLOON AND IT IS BELIEVED IT WAS LEFT IN THE PATIENT'S ANATOMY.

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

  MAUDE report 17110822 ↗
• MalfunctionMay 18, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IV) CATHETER WAS USED TO TREAT A LESION LOCATED IN THE ILIAC ARTERY. ALL 300 PULSES WERE DELIVERED SUCCESSFULLY. AFTER DELIVERING THE PULSES, THE PHYSICIAN ATTEMPTED TO PULL OUT THE CATHETER HOWEVER, THE BALLOON COULD NOT BE DEFLATED. HOWEVER, THE PHYSICIAN WAS ABLE TO GET THE BALLOON TO THE COMMON FEMORAL ARTERY AND UNDER ULTRASOUND, THE PHYSICIAN PUNCTURED THE BALLOON WITH A MICRONEEDLE. AFTER IT WAS DEFLATED, THE BALLOON WAS ABLE TO BE SAFELY REMOVED FROM THE SHEATH. THERE WAS NO PATIENT SEQUELAE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955794 ↗
• MalfunctionNov 4, 2022Break; Entrapment of Device; Retraction Problem; Material Separation; Detachment of Device or Device Component; Break; Entrapment of Device; Retraction Problem; Material Separation; Detachment of Device or Device Component

  AN M5 PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TREAT THE ILIAC ARTERY DUE TO OCCLUSIVE DISEASE/CLAUDICATION. ACCESS TO THE LESION WAS OBTAINED VIA FEMORAL APPROACH. IT WAS REPORTED THAT AFTER THE M5+ BALLOON DELIVERED 181 PULSES TO THE TARGET LESION, THE PHYSICIAN DEFLATED THE BALLOON, PULLED IT BACK TOWARDS THE LESION AND BACK INTO THE SHEATH. HOWEVER, THE DISTAL BALLOON MARKER BROKE OFF COMPLETELY AND THE BALLOON FELL INSIDE THE PATIENT'S ANATOMY. THE BALLOON IS LEFT INSIDE THE PATIENT AND THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE IT. THE PHYSICIAN DECIDED THAT THE BEST SOLUTION WAS TO STENT OVER THE SEPARATED PIECE BY TRAPPING IT TO THE WALL WITH THE STENT. THERE IS NO PLAN TO REMOVE THE BALLOON SINCE THE STENT WAS PLACED AS PER THE NORMAL TREATMENT. THE PHYSICIAN FELT IT WAS A DIFFICULT PROCEDURE THAT TURNED OUT SUCCESSFULLY. THE PATIENT WAS DISCHARGED TO HOME THE SAME DAY WITH NO CLINICAL SEQUELAE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15728643 ↗