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

Model Number	BC0415C-ID
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: intraoperative pressure to 0.30cc, the balloon burst in the rated range.The procedure was completed after the same type of balloon was replaced.It was a sudden loss of pressure when the balloon burst.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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Correction: corrected model number and udi in section d.Items received for investigation: scepter c.The balloon was returned ruptured.The hub was returned intact with residual contrast in the inflation port.The investigation of the returned balloon catheter found 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 rupture, but this condition is consistent with the device experiencing forces over specification due to over inflation.
Event or Problem Description
As reported: intraoperative pressure to 0.30cc, the balloon burst in the rated range.The procedure was completed after the same type of balloon was replaced.It was a sudden loss of pressure when the balloon burst.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: 20072029
• Report Number: 2032493-2024-00634
• Device Sequence Number: 17769095
• Product Code: DQY
• UDI-Device Identifier: 00842636020546
• UDI-Public: (01)00842636020546(11)230920(17)260831(10)0000425878
• 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): 10/01/2024

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 Expiration Date: 08/31/2026
• Device Model Number: BC0415C-ID
• Device Lot Number: 0000425878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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