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

Model Number	BC0410C-ID-700
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination could not be performed as this information was not available or provided at the time.The device was reported to be available for return to the manufacturer for evaluation but has not yet been returned.The liquid embolic reflux and distal leak 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.
Event or Problem Description
It was reported that during a dural arteriovenous fistula (davf) embolization procedure with squid, the scepter c was inserted after preparation in the middle meningeal artery (mma) and inflated.During the injection of the squid injection, liquid embolic reflux was identified.Added pressure was applied; however, the balloon did not hold the pressure.After the scepter c balloon was removed, it was flushed with dmso, and distal leak was observed.There was no patient injury reported, and the patient was reported to be stable with no changes after appearance to the hospital.
Additional Manufacturer Narrative
The investigation of the returned balloon catheter found the hub occluded with material consistent with dried contrast from the device preparation.After bypassing the hub, the balloon was inflated, and the investigation found a pinhole leak causing the device to progressively deflate on its own, 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.
Event or Problem Description
Please see section h10 for device investigation results.

• Brand Name: SCEPTER C
• Common Device Name: OCCLUSION BALLOON CATHETER
• 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: 16640427
• Report Number: 2032493-2023-00638
• Device Sequence Number: 14794439
• Product Code: DQY
• UDI-Device Identifier: 00842429103388
• UDI-Public: (01)00842429103388(11)210607(17)240531(10)21060755H
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 05/31/2024
• Device Model Number: BC0410C-ID-700
• Device Catalogue Number: BC0410C
• Device Lot Number: 21060755H
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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: 27 YR
• Patient Sex: Male
• Patient Weight: 83 KG