XIENCE Skypoint™ 1804275-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648233166), received between Jun 21, 2021 and Nov 13, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS MID-LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT IS 90% STENOSED. A 6F SYSTEM WAS AND PRE-DILATION WAS PERFORMED SEVERAL TIMES IN LAD #7 WITH A 2X5X15MM NON-ABBOTT BALLOON. DURING ADVANCEMENT OF THE 2.75X18MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES), RESISTANCE WAS FELT DUE TO ANATOMY BUT ULTIMATELY CROSSED. DURING INFLATION OF THE XIENCE SKYPOINT, THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. THE XIENCE SKYPOINT DES WAS SIMPLY WITHDRAWN. A 2.75X15MM NON-ABBOTT BALLOON WAS USED FOR ADDITIONAL DILATIONS. A 2.5X18MM XIENCE SKYPOINT DES WAS SUCCESSFULLY DEPLOYED AND POST-DILATION PERFORMED WITH A 2.75X15MM NON-ABBOTT BALLOON; THEREFORE, COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23548180 ↗
• InjuryDec 18, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  MEDWATCH MW5162648 RECEIVED WHICH STATES: THE STENT WAS PREPARED TO LOAD ONTO THE WIRE AND VISUALIZED. WHEN THE STENT GOT THROUGH THE CATHETER TO THE CORONARY THE STENT WAS VISIBLY DAMAGED. THE PHYSICIAN PULLED THE STENT DELIVERY SYSTEM OUT THE OF THE SYSTEM AND NOTED THE STENT WAS NOT ON THE SYSTEM. STENT WAS NOT IDENTIFIED. PHYSICIAN REMOVED PRODUCT, EXCEPT THE SHEATH. HE INSERTED A DIAGNOSTIC CATHETER TO TAKE FLURO GUIDED IMAGES OF THE UPPER BODY (EXCLUDING HEAD AND NECK) AND LOWER EXTREMITIES. NO STENT WAS VISUALIZED. PRODUCT RETAINED AND KEPT FOR REVIEW. PHYSICIAN ABORTED INTERVENING ON THAT VESSEL. CASE WAS FINISHED AND PATIENT WAS TAKEN TO POST-OP AREA. IMAGING ORDERS PLACED TO EVALUATE FOR RETAINED OBJECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20964330 ↗
• MalfunctionMar 13, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE 1ST DIAGONAL IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. REPORTEDLY, THE NC TREK NEO RX 3.00 X 12MM WAS ADVANCED FIRST IN THE DISTAL LAD. THEN, THE XIENCE SKYPOINT DES 2.75 X 18 RX US STENT DELIVERY SYSTEM WAS UNABLE TO ADVANCE OUT OF THE GUIDE CATHETER. THE PHYSICIAN LOST GUIDE ENGAGEMENT AND WIRE POSITION, AND PULLED BOTH DEVICES INTO THE GUIDE CATHETER. ONCE THE GUIDE CATHETER WAS RE-ENGAGED, AND THE PHYSICIAN HAD WIRE PLACEMENT, THE NC TREK NEO WAS RE-ADVANCED INTO THE DISTAL LAD (BUT NOT INFLATED). THE SDS WAS UNABLE TO ADVANCE, WITH RESISTANCE. THEN THE SDS WAS REMOVED AND NOTICED THAT THE STENT HAD SEPARATED FROM THE SHAFT OUTSIDE THE PATIENT. THE NC TREK NEO APPEARED TO BE KINKED ON THE SHAFT. BOTH DEVICES WERE NOT ABLE TO BE USED AND SET ASIDE. A NEW STENT AND BALLOON OF THE SAME SIZE WERE OPENED AND SUCCESSFULLY USED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899111 ↗
• MalfunctionNov 20, 2023Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 95% STENOSED. THE 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, RESISTANCE WAS FELT WITH ANATOMY AND THE PROXIMAL SHAFT BECAME BENT. THE SDS SEPARATED AT THE BENT SEGMENT ONCE REMOVED FROM THE PATIENT'S ANATOMY. A NEW 2.5X18MM SKYPOINT STENT WAS SUED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18176651 ↗
• InjuryDec 13, 2022Material Rupture; Deformation Due to Compressive Stress; Material Rupture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RAMUS ARTERY WITHOUT CALCIFICATION OR TORTUOSITY. THE 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS INFLATED BUT WAS NOTED TO NOT HOLD THE PRESSURE CORRECTLY AND STOPPED INFLATING DURING THE FIRST INFLATION AT AN UNKNOWN PRESSURE AND EITHER THE BALLOON RUPTURED OR THE HYPOTUBE RUPTURED [KINKED]. THE SDS WAS REMOVED, HOWEVER, THE HALF DEPLOYED STENT WAS LEFT IN THE LEFT MAIN ARTERY. THE STENT WAS REMOVED BY USING A SNARE DEVICE. THE SDS WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970354 ↗
• MalfunctionDec 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX (PCX) ARTERY WITH HEAVY CALCIFICATION. A ROTABLATOR AND IMPELLA WERE USED; HOWEVER, THE ROTABLATING WAS NOT SUCCESSFUL. THE 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD NO RESISTANCE DURING ADVANCEMENT, HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATMS) AND THE STENT WAS NOT DEPLOYED. THE STENT DID NOT GET DISLODGED FROM THE SDS AND THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT'S ANATOMY. THE SDS WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO ADVERSE PATIENT EFFECT. ALTHOUGH THERE WAS REPORTED DELAYS IN THE PROCEDURE, IT WAS CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS; THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924344 ↗
• MalfunctionSep 12, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS NOTED ALSO NOTED DURING REMOVAL WITH ANATOMY. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406699 ↗
• MalfunctionAug 23, 2022Difficult to Remove; Failure to Advance; Material Split, Cut or Torn; Difficult to Remove; Failure to Advance; Material Split, Cut or Torn

  USER FACILITY MEDWATCH REPORT (MW5111021) RECEIVED STATING: "STENT USED DURING CORONARY PTCA WAS UNABLE TO BE ADVANCED, SO IT WAS REMOVED. THERE WAS DIFFICULTY REMOVING IT THROUGH THE GUARD CATHETER. EVERYTHING WAS PULLED OUT, CATHETER, GUIDEWIRE AND STENT. UPON OBSERVATION, THE STENT HAD BECOME TORN OR DAMAGED AT THE BASE. ABBOTT XIENCE SKYPOINT 2.75 MM X18 MM, REF 1804275-18, LOT 1120641. FDA SAFETY REPORT ID # (B)(4). ADDITIONAL INFORMATION RECEIVED: AFTER LESION PREPARATION, THE 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO ADVANCE DUE TO HEAVY CALCIUM AND MODERATE TORTUOSITY 90+% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). AFTER REMOVAL OF THE SDS, THE DISTAL END OF THE STENT HAD A NOTED DEFORMITY DUE TO THE DOTTERING TECHNIQUE ON THE CALCIUM. ANOTHER 2.75MM X 18 MM XIENCE SKYPOINT STENT WAS DEPLOYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280205 ↗
• MalfunctionJul 20, 2022Failure to Advance; Material Split, Cut or Torn

  STENT USED DURING CORONARY PTCA WAS UNABLE TO BE ADVANCED, SO IT WAS REMOVED. THERE WAS DIFFICULTY REMOVING IT THROUGH THE GUARD CATHETER. EVERYTHING WAS PULLED OUT, CATHETER, GUIDEWIRE AND STENT. UPON OBSERVATION, THE STENT HAD BECOME TORN OR DAMAGED AT THE BASE. ABBOTT XIENCE SKYPOINT 2.75 MM X18 MM, REF 1804275-18, LOT 1120641. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15077750 ↗
• MalfunctionApr 21, 2022Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DIAGONAL ARTERY THAT WAS MODERATELY CALCIFIED. THE XIENCE SKYPOINT SHAFT KINKED AND BROKE DURING INSERTION INTO 6FR GUIDE CATHETER. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT AND THE DEVICE WAS EASILY REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14178762 ↗
• MalfunctionMar 17, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. DILATATION OF THE MLAD AND INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. AN ASAHI SION BLUE GUIDE WIRE WAS INSERTED INTO THE DISTAL TIP OF THE 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) AND THE SDS WAS ADVANCED, HOWEVER, RESISTANCE WAS FELT WITH THE GUIDE WIRE. A BLOOD CLOT WAS NOTED ON THE GUIDE WIRE PRIOR TO USE OF THE SDS AND WHILE THE SDS WAS ADVANCED OVER THE GUIDE WIRE, THE BLOOD CLOT WAS ALSO ADVANCED TOGETHER WITH THE SDS. THE SDS WAS ADVANCED WITH THE RESISTANCE NOTED, HOWEVER, THE SDS WAS STUCK IN FRONT OF THE Y-CONNECTOR. THE SDS WAS ATTEMPTED TO BE REMOVED WITH NOT MUCH FORCE ONCE TO WIPE THE BLOOD CLOT OFF BUT THE DISTAL TIP OF THE SDS GOT SEPARATED DURING REMOVAL. THE SDS WAS REMOVED FROM THE GUIDE WIRE AND THE BROKEN DISTAL TIP THAT REMAINED ON THE GUIDE WIRE WAS ALSO REMOVED BY SIMPLY WITHDRAWING. A SAME SIZE NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13793222 ↗
• InjuryFeb 28, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED OSTIAL CIRCUMFLEX. IT WAS NOTED A STENT WAS ALREADY IMPLANTED IN THE OSTIAL CIRCUMFLEX. A XIENCE SKYPOINT DRUG ELUTING STENT (DES) 2.75 X 18MM WAS INSERTED AND ADVANCED TO THE TARGET LESION. IT WAS NOTED THERE WAS RESISTANCE DURING ADVANCEMENT AS THE SKYPOINT GOT HUNG UP ON THE PROXIMAL END OF THE IMPLANTED STENT IN THE OSTIAL CIRCUMFLEX. IT WAS THEN OBSERVED THE SKYPOINT STENT HAD DISLODGED FROM THE DELIVERY CATHETER. THE DELIVERY CATHETER WAS REMOVED AND AN UNSPECIFIED BALLOON CATHETER WAS INSERTED TO DEPLOY THE DISLODGED STENT. ADDITIONALLY, THERE WAS A PREVIOUS UNSPECIFIED STENT PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY THAT ALSO MAY HAVE PLAYED A ROLE WITH DIFFICULTY IN PLACEMENT OF THE SKYPOINT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620199 ↗
• InjuryFeb 22, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TO THE RIGHT CORONARY ARTERY (RCA) AND THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). THE RCA WAS TREATED FIRST WITH AN UNSPECIFIED DEVICE. THE 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED AND ATTEMPTED TO BE INFLATED; HOWEVER, UNDER CINE THE SHAPE APPEARED TO BE DOG-BONED. THE PRESSURE WAS ATTEMPTED TO BE INCREASED FROM 6 ATMOSPHERES, BUT THE GAGE PRESSURE OF AN NON-ABBOTT INDEFLATOR WOULD NOT INCREASE. A LEAK OCCURRED FROM THE DISTAL END OF THE DELIVERY SYSTEM AS THE INDEFLATOR WAS BEING USED. THE STENT WAS DEPLOYED AND PATIENT WENT INTO SHOCK AND A INTRA-AORTIC BALLOON PUMP (IABP) WAS USED AS WELL AS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). ANOTHER UNSPECIFIED BALLOON WAS USED EXPAND THE DEPLOYED STENT FIRMLY INTO THE VESSEL WALL. ADDITIONALLY, AN AIR EMBOLISM OCCURRED AND UNKNOWN GUIDING CATHETER WAS INSERTED DEEPLY TO DRAW AIR AND RECOVER THE FLOW. THE PATIENT REGAINED CONSCIOUSNESS AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Cardiogenic Shock; Syncope/Fainting

  MAUDE report 13579207 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR DESCENDING ARTERY. THE 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. HOWEVER, DURING THE FIRST INFLATION TO 14 ATMOSPHERES TO 30 SECONDS, THE BALLOON DID NOT HOLD PRESSURE, THERE WAS A HOLE IN THE BALLOON. THE STENT WAS DEPLOYED AT THE INTENDED SITE AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. A 3.0X15 MM NC TREK WAS USED TO POST DILATE THE SKYPOINT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498198 ↗
• MalfunctionDec 20, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A 2.75X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. ONCE THE SDS WAS REMOVED TO PERFORM DILATATION WITH AN UNSPECIFIED BALLOON DILATATION CATHETER THE DISTAL TIP APPEARED TO BE FLARED AND RESISTANCE WITH ANATOMY WAS ALSO NOTED DURING REMOVAL. BALLOON DILATATION WAS PERFORMED AND ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043452 ↗
• MalfunctionAug 6, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE MILDLY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY (PLCX). TWO XIENCE SKYPOINT STENT DELIVERY SYSTEMS WERE ADVANCED AT THE SAME TIME INSIDE THE GUIDING CATHETER (GC); HOWEVER, THE DEVICES BECAME STUCK DURING ADVANCEMENT AND WERE DIFFICULT TO REMOVE FROM THE GC. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289444 ↗
• MalfunctionJun 21, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 2.75X18 XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. IT WAS NOTED THAT RESISTANCE WAS MET WITH ANATOMY DURING ADVANCEMENT AND REMOVAL OF THE DEVICE. AN UNSPECIFIED BALLOON DILATATION CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORT. NO ADDITIONAL INFORMATION WAS PROVIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032502 ↗