MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	BC0415C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: during the balloon-assisted-coiling of a media aneurysm, the balloon burst within the vessel.The balloon wasn't inflated completely ¿ around 50-70%.When the balloon had burst, there was a quick loss of volume in a short time.The event had no influence on the patient's outcome.
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 is in transit to be returned to the manufacturer for evaluation but has not yet been received by the manufacturer.The reported issue 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
Items returned for investigation: scepter c.Items not returned for investigation: n/a.The balloon was returned ruptured, and the coil of the inflation lumen was observed to be dislodged near the proximal end of the balloon.No functional testing for inflation could be conducted due to the balloon rupture.The investigation of the returned balloon catheter found the coil of the inflation lumen dislodged near the proximal end of the balloon and the balloon ruptured, 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 damage, but the damage is consistent with the device experiencing forces over specification due to over inflation.
Event or Problem Description
As reported: during the balloon-assisted-coiling of a media aneurysm, the balloon burst within the vessel.The balloon wasn't inflated completely ¿ around 50-70%.When the balloon had burst, there was a quick loss of volume in a short time.The event had no influence on the patient's outcome.

• Brand Name: SCEPTER C
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: 19280646
• Report Number: 2032493-2024-00367
• Device Sequence Number: 17726365
• Product Code: MJN
• UDI-Device Identifier: 00842429103395
• UDI-Public: (01)00842429103395(11)231020(17)260930(10)0000445587
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110741
• 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): 06/14/2024

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: 09/30/2026
• Device Model Number: BC0415C
• Device Lot Number: 0000445587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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: Female