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

Model Number	BC0411XC-ID-700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
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 was discarded and not available for return to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stroke as potential complications associated with use of the device.
Event or Problem Description
It was reported during treatment of an embolization of a arteriovenous malformation (avm) and congestive cardiac failure (ccf) with a scepter balloon, multiple coils and a competitor's liquid embolic system, the embolic syringe broke off at the hub of the scepter xc balloon catheter.The microcatheter and balloon were removed from the patient.The patient was reported to have a stroke during the procedure and the physician embolized other feeding vessels.
Additional Manufacturer Narrative
Received additional information via email.It was stated that cause was most likley a faulty syringe that microvention inc.Does not manufacturer.It cannot be determined in which device the syringe broke as many catheters were used in the case.The occulusion of other feeding vessels was considered to be suboptimal.

• 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: 15089892
• Report Number: 2032496-2022-00289
• Device Sequence Number: 5101787
• Product Code: MJN
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)220128(17)241231(10)0000151820
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2022

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: 12/31/2024
• Device Model Number: BC0411XC-ID-700
• Device Catalogue Number: BC0411XC
• Device Lot Number: 0000151820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY DUO MICROCATHETER (QUANTITY OF 3) SCEPTER; SCEPTER MINI
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown