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

Model Number	BC0411XC-ID-700
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
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 manufacturing of the device.The device was returned to the manufacturer for analysis and the investigation is currently underway.A supplemental report will be submitted when the investigation is completed.
Event or Problem Description
It was reported that the physician was treating an acom aneurysm on the left and a coil embolization in remodeling technique was planned.Reportedly, during the first inflation inside the patient the scepter xc balloon ruptured distally and contrast leaked out of the tip.The balloon was removed completely from the patient body.No fragments were left in the patient.A a new balloon was exchanged and the case continued and completed successfully.No injury caused by this issue and the patient is doing well.
Additional Manufacturer Narrative
Additional information: h6, h10 (summary device evaluation).Summary device evaluation: the investigation of the returned balloon catheter found no rupture on the balloon; however, the device did exhibit a pinhole leak at the distal side of the balloon during inflation testing, 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 pin hole, but pin holes are consistent with the balloons experiencing forces over specification.Per the event description, the balloon was able to inflate and deflate without issue during prep; therefore, the damage to the balloon likely occurred during the process of advancing the device to the target site during the procedure.

• Brand Name: SCEPTER XC
• 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: 16343484
• Report Number: 2032493-2023-00556
• Device Sequence Number: 12492215
• Product Code: MJN
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)220921(17)250831(10)0000260846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113698
• 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): 01/25/2023

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: 08/31/2025
• Device Model Number: BC0411XC-ID-700
• Device Catalogue Number: BC0411XC
• Device Lot Number: 0000260846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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: 49 YR
• Patient Sex: Female