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

Model Number	BC0410C-ID-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Items returned: n/a.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: 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.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu): potential complications potential complications include, but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.Directions for use attach a 2-way stopcock to a 1cc syringe filled with appropriate contrast solution.Prime the 2-way stopcock so that no air is present.Slowly inflate the balloon to the recommended volume to achieve the desired diameter as described in table 3.Warning: do not exceed the maximum recommended inflation volume as balloon rupture may occur.Warning: always inflate and deflate the balloon while visualizing under fluoroscopy to ensure patient safety.After inflation, lock the stopcock if desired.If desired, remove the guidewire from the balloon catheter and prepare per the respective diagnostic or therapeutic agent ifu(s) for delivery through the guidewire lumen.Warning: excessive pressure higher than 700psi (4826kpa, 47.6atm) may cause leakage or rupture of the guidewire lumen.When deflating balloon, use fluoroscopy to ensure complete deflation prior to removal.See table 1 for respective deflation times.After procedure is complete, slowly remove the balloon catheter and guidewire.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.
Event or Problem Description
It was reported that the balloon was prepared properly and burst upon inflation during the procedure.The procedure was completed by using other product.No patient harm or injury was reported.

• 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 ; 38 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16376613
• Report Number: 2032493-2023-00571
• Device Sequence Number: 12357734
• Product Code: MJN
• UDI-Device Identifier: 00842429103388
• UDI-Public: (01)00842429103388(11)220510(17)250430(10)0000190310
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K113698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: 04/30/2025
• Device Model Number: BC0410C-ID-700
• Device Catalogue Number: BC0410C
• Device Lot Number: 0000190310
• Was Device Available for Evaluation?: No
• 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: 01/31/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male