Scepter C BC0410C-IDRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00842636020539), received between Oct 27, 2017 and Aug 20, 2020 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AFTER INFLATION IN THE PATIENT, THE BALLOON DEFLATION WAS TOO SLOW. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435237 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EMBOLIZATION TREATMENT WAS ATTEMPTED FOR A MENINGIOMA. DURING THE INJECTION OF A LIQUID EMBOLIC AGENT (SQUID 18) THROUGH THE SCEPTER BALLOON CATHETER, NOTHING APPEARED TO EXIT FROM THE DISTAL BALLOON LUMEN; HOWEVER, A LEAKAGE OF THE SQUID WAS OBSERVED AT THE LEVEL OF A BRANCH OF THE EXTERNAL CAROTID ARTERY. THE INJECTION WAS STOPPED AND ARTERIOGRAPHY OF THE RIGHT EXTERNAL CAROTID AND RIGHT COMMON CAROTID ARTERIES DEMONSTRATED "SLOWED DOWN BUT PERSISTENT" FLOW WITHIN THE RIGHT INTERNAL MAXILLARY ARTERY. THERE WAS NO REFLUX WITHIN THE BRANCHES OF THE RIGHT INTERNAL CAROTID ARTERY. NO ADDITIONAL INTERVENTION WAS PERFORMED. POST-PROCEDURE, THE PATIENT EXPERIENCED HEMIFACIAL PAIN UPON AWAKENING THAT WAS TREATED WITH ANTALGIC. THE CLINICAL CONSEQUENCES OF THE EVENT INCLUDED "AN EXTENSION OF THE INTERVENTION, INCOMPLETE EMBOLIZATION OF THE RIGHT MIDDLE MENINGEAL ARTERY DUE TO OFF-SITE EMBOLIZATION WITHIN THE INTERNAL MAXILLARY ARTERY, AND A RISK OF EMBOLIZATION OF THE ARTERIAL BRANCHES OF THE EXTERNAL CAROTID ARTERY." NO ADDITIONAL ACTIONS WERE TAKEN AT THE FACILITY FOR CARE OF THE PATIENT. THERE WAS NO REPORTED NEUROLOGICAL DEFICIT OR SEQUELA AS A RESULT OF THE EVENT

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 10068342 ↗
• MalfunctionApr 17, 2020Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN INTERNAL CAROTID ARTERY ANEURYSM. A (NON-MICROVENTION) FLOW-DIVERTER STENT WAS DEPLOYED, BUT IT DID NOT OPEN PROXIMALLY. DURING AN IN-STENT INFLATION WITH THE SCEPTER BALLOON TO IMPROVE THE WALL APPOSITION, THE BALLOON RUPTURED. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9975002 ↗
• MalfunctionApr 17, 2020Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN INTERNAL CAROTID ARTERY ANEURYSM. A (NON-MICROVENTION) FLOW-DIVERTER STENT WAS DEPLOYED, BUT IT DID NOT OPEN PROXIMALLY. DURING AN IN-STENT INFLATION WITH THE SCEPTER BALLOON TO IMPROVE THE WALL APPOSITION, THE BALLOON RUPTURED. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9974919 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A SUBARACHNOID HEMORRHAGE, HUNT AND HESS GRADE 2. CT IMAGING DEMONSTRATED TWO ANEURYSMS IN THE ANTERIOR COMMUNICATING ARTERY, FISHER SCALE GRADE 2. ON (B)(6) 2019, BALLOON ASSISTED COIL EMBOLIZATION WAS ATTEMPTED AS TREATMENT. THE SCEPTER BALLOON WAS INFLATED IN THE ACOM ARTERY WITH ITS DISTAL END IN THE LEFT A2 SEGMENT AND THE PROXIMAL END IN THE RIGHT A1 SEGMENT. AFTER PLACEMENT OF THE SECOND COIL IN THE LARGER ANEURYSM, CONTROL ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION NEAR THE SMALLER LEFT-SIDED ANEURYSM, WHICH WAS LIKELY A NECK RUPTURE DURING INFLATION OF THE BALLOON. A FOLLOW-UP ANGIOGRAM REVEALED THAT THE CONTRAST EXTRAVASATION HAD SUBSIDED, AND THERE APPEARED TO BE AN AREA OF ACUTE THROMBUS FORMATION NEAR THE NECK OF THE SMALLER ANEURYSM, WHICH LIKELY OCCLUDED THE RUPTURE SITE. A DILATION OF THE PROXIMAL A2 SEGMENT OF THE LEFT ACOMM ARTERY WAS ALSO NOTED, WHICH WAS LIKELY INDICATIVE OF A PSEUDOANEURYSM. COIL EMBOLIZATION OF THE SMALLER ANEURYSM RESUMED, AND FOLLOW-UP ANGIOGRAMS DEMONSTRATED THE COIL MASS WAS WELL SEATED WITHIN THE LARGER ANEURYSM, THE PARENT VESSEL WAS WIDELY PATENT, AND THERE WAS NO FURTHER EVIDENCE

  Patient problems: Hemorrhage, Subarachnoid; Rupture; Thrombus

  MAUDE report 8963145 ↗
• InjuryMay 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE TREATMENT OF A MIDDLE MENINGEAL ARTERY, ONYX WAS DELIVERED THROUGH THE SCEPTER C BALLOON CATHETER, AND THE BALLOON CATHETER RUPTURED APPROXIMATELY 10CM FROM THE BALLOON. ONYX LEAKED FROM THE CATHETER AND CAUSED COMPLETE OCCLUSION OF THE SPHENOPALATINE ARTERY. THERE WAS NO REPORTED ISSUE WITH THE REMOVAL OF THE BALLOON CATHETER. THE PATIENT'S CONDITION WAS REPORTED TO BE AT BASELINE.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 8589124 ↗
• MalfunctionApr 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED IN THE PATIENT DURING THE PROCEDURE. THERE WAS NO REPORTED INTERVENTION, PATIENT INJURY, OR HEALTH DAMAGE. THE PATIENT 'S CONDITION WAS REPORTED TO BE "NORMAL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525556 ↗
• MalfunctionApr 17, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING BALLOON-ASSISTED TREATMENT OF AN EXTRACRANIAL COGNARD TYPE III DAVF, THE SCEPTER BALLOON WOULD NOT DEFLATE AFTER THE PHIL WAS INJECTED. THE VESSEL WAS RUPTURED IN ORDER TO REMOVE THE BALLOON. THE FISTULA WAS SHUT DOWN COMPLETELY AND THE PATIENT WAS REPORTED TO HAVE DONE WELL POST-PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 8525172 ↗
• MalfunctionApr 3, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED AFTER THE FIRST INFLATION INSIDE THE ARTERY. THE BALLOON WAS EVENTUALLY ABLE TO BE DEFLATED; HOWEVER, IT WAS VERY DIFFICULT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE DOING VERY WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479290 ↗
• MalfunctionFeb 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED DURING THE PROCEDURE. THE BALLOON WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8346214 ↗
• MalfunctionSep 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED IN THE PATIENT DURING THE FIRST INFLATION ATTEMPT. THE BALLOON HAD BEEN PINCHED TO PREVENT INFLATION DURING PREPARATION FOR USE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885996 ↗
• MalfunctionSep 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED IN THE PATIENT DURING THE FIRST INFLATION ATTEMPT. THE BALLOON HAD BEEN PINCHED TO PREVENT INFLATION DURING PREPARATION FOR USE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885994 ↗
• MalfunctionAug 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED DURING THE PROCEDURE. THE BALLOON WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801823 ↗
• MalfunctionJun 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PROCEDURE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT'S CONDITION WAS REPORTED TO BE "NORMAL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643477 ↗
• MalfunctionNov 22, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE USUAL PREPARATION PROCESS, THE BALLOON WAS SOAKED. THE BALLOON, HOWEVER, WAS NOT INFLATED AND DEFLATED AT THAT TIME, BUT WAS THEN MANUALLY "PINCHED" TO ACHIEVE BETTER TRACKING. DURING INFLATION OF THE BALLOON WITH CONTRAST ONCE THE BALLOON HAD BEEN PLACED IN THE PATIENT, THE BALLOON APPEARED TO BE RUPTURED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7054859 ↗
• MalfunctionOct 27, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE TREATMENT OF A FACIAL ARTERIOVENOUS MALFORMATION, THE BALLOON BROKE. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT IS REPORTED TO BE OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985644 ↗