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

Model Number	BC0420C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: internal carotid cavernous sinus leak (left side).During the procedure, found that the balloon was ruptured after filling to 0.4cc, and the whole device was removed.Examination of the patient's blood vessels showed no abnormality.After readjusting the position, replaced with a new 4*20 balloon, which was filled to 0.4cc without abnormalities and the effect was satisfactory.The microcatheter was in place, 8 coils such as 20* 50,18 * 44,16 *39 were filled successively, and 8 glue were injected through other microcatheter.The angiography effect was satisfactory and the procedure was completed.The side wall liquid of the balloon is squeezes liquid out, in a jet shape, and the side wall of the balloon has holes.Patient is fine.
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 was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Correction: corrected udi in section d.Items returned for investigation: scepter c the balloon was returned ruptured.The catheter shaft was also found to be kinked at the strain relief.The investigation of the returned balloon catheter found the catheter shaft kinked at the strain relief and the balloon ruptured as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the kink in the catheter shaft, but the kink is consistent with the device experiencing forces exceeding the shaft's yield strength.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
As reported: internal carotid cavernous sinus leak (left side).During the procedure, found that the balloon was ruptured after filling to 0.4cc, and the whole device was removed.Examination of the patient's blood vessels showed no abnormality.After readjusting the position, replaced with a new 4*20 balloon, which was filled to 0.4cc without abnormalities and the effect was satisfactory.The microcatheter was in place, 8 coils such as 20* 50,18 * 44,16 *39 were filled successively, and 8 glue were injected through other microcatheter.The angiography effect was satisfactory and the procedure was completed.The side wall liquid of the balloon is squeezes liquid out, in a jet shape, and the side wall of the balloon has holes.Patient is fine.

• 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: 20218505
• Report Number: 2032493-2024-00684
• Device Sequence Number: 7727307
• Product Code: DQY
• UDI-Device Identifier: 00842636020553
• UDI-Public: (01)00842636020553(11)230720(17)260630(10)0000394744
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 Expiration Date: 06/30/2026
• Device Model Number: BC0420C
• Device Lot Number: 0000394744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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 Sex: Unknown