MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER MINI; VASCULAR CLAMP

Model Number	BC0210M
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an arterio venous malformation (avm) embolization procedure where both scepter balloon and catheter separation occurred.During the procedure, 25% phil¿ was injected using scepter mini for embolization of avm.After embolization, it was difficult to remove the mv scepter mini balloon microcatheter because the balloon was trapped by the phil¿ cast.The scepter mini was fractured, and the distal part remained within the patient.The distal part of the catheter was removed with nidus by surgery.The vertebral artery was occluded after embolization and no severe injury occurred.The patient is reported to be under ventilation.However, the reason or the relationship to the procedure is unknown.
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 product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The scepter mini balloon catheter instructions for use (ifu) states the need to verify balloon catheter compatibility when using other ancillary devices commonly used in intravascular procedures and identifies the scepter balloon catheter has been tested for compatibility with onyx¿ liquid embolic only.
Additional Manufacturer Narrative
H11: corrections: b1: adverse event, not product problem.The device was not actually available for investigation.An investigation could not be performed and thus the event as described could not be confirmed.
Additional Manufacturer Narrative
H11: corrections: d4: corrected lot, udi, and expiration date.G2: additional selections.G3: applicable to follow up 1 and follow up 2.H6: add 3331 to type of investigation.Additional corrections were discovered during auditing of the file so a second supplemental has been submitted.Lot search information is also available, which was not included on the initial and first supplemental.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.

• Brand Name: SCEPTER MINI
• Common Device Name: VASCULAR CLAMP
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14124315
• Report Number: 2032493-2022-00154
• Device Sequence Number: 11335433
• Product Code: MJN
• UDI-Device Identifier: 00842429110850
• UDI-Public: (01)00842429110850(11)210218(17)240131(10)21021813H
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: BC0210M
• Device Catalogue Number: W5-5-3
• Device Lot Number: 21021813H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 06/09/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/16/2022; 06/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROVENTION PHIL¿ LIQUID EMBOLIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 73 KG