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

Model Number	BC0415C-ID-700-AL
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: patient treated for a left sylvian aneurysm.During the performance of angioplasty, at the first swelling, on two occasions, a rupture of the balloon occurs.The lining of the balloons appears to be streaked, which led to a crack when they were inflated.When the first balloon ruptured, it was a sudden loss of pressure.No consequences for the patient.This report is for the first balloon rupture of the procedure.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Items returned for investigation: scepter c balloon microcatheter.Scepter c was returned deflated.The hub was intact but was occluded with residual contrast fluid.Attempts to inflate the balloon via the inflation port failed due to the hub occlusion.The hub was bypassed and all subsequent attempts to inflate the balloon also failed.Further inspection found the distal inflation lumen to be occluded with contrast.The investigation of the returned balloon catheter found the hub occluded with material consistent with dried contrast from the device preparation.After the hub was bypasses, the balloon was attempted to be inflated; however, the balloon was unable to be inflated.Further inspection of the device found the distal inflation lumen also occluded with dried contrast, which prevented the balloon from inflating.Due to the inflation lumen occlusion, this investigation could not inflate the balloon to determine if damage such as pinhole leaks were present.No tears or any other visible breaches in the balloon were observed.
Event or Problem Description
As reported: patient treated for a left sylvian aneurysm.During the performance of angioplasty, at the first swelling, on two occasions, a rupture of the balloon occurs.The lining of the balloons appears to be streaked, which led to a crack when they were inflated.When the first balloon ruptured, it was a sudden loss of pressure.No consequences for the patient.This report is for the first balloon rupture of the procedure.

• Brand Name: SCEPTER C
• 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: 20604687
• Report Number: 2032493-2024-00798
• Device Sequence Number: 18183703
• Product Code: DQY
• UDI-Device Identifier: 00842429117552
• UDI-Public: (01)00842429117552(11)240217(17)270131(10)0000528006
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: BC0415C-ID-700-AL
• Device Lot Number: 0000528006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Unknown