MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC; CATHETER, PERCUTANEOUS

Model Number	BC0411XC-ID-700-AL
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production related issues relevant to the complaint that occurred during the manufacturing of the device.The device is reported available but has not been returned to the manufacture for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.Instructions for use (ifu) identifies balloon rupture or leakage as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that the balloon burst in the vessel during the procedure.There was no clinical consequence, no patient injury was reported.
Additional Manufacturer Narrative
Items returned for investigation: scepter xc.Items not returned for investigation: n/a.The balloon was returned deflated with residual contrast.The hub was intact with residual contrast in the inflation port.A rupture was observed at the distal marker band of the balloon; the surface of the balloon was coated with dye during the investigation (note: the dye used is water and alcohol soluble), and after rinsing, the dye was observed to have seeped into the balloon through the rupture.The investigation of the returned balloon catheter found the balloon ruptured at the distal marker band, which is consistent with the alleged product issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the rupture, but this condition is consistent with the device experiencing forces over specification due to over inflation.
Event or Problem Description
A correction has been made to section d2a.

• Brand Name: SCEPTER XC
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19217752
• Report Number: 2032493-2024-00338
• Device Sequence Number: 12822341
• Product Code: DQY
• UDI-Device Identifier: 00842429117583
• UDI-Public: (01)00842429117583(11)240123(17)261231(10)0000501469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BC0411XC-ID-700-AL
• Device Lot Number: 0000501469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female