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

Model Number	BC0210M-US
Medical Device Problem Codes	Break (1069); Failure to Deflate (4060)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Hydrocephalus (3272); Ischemia Stroke (4418)
Date of Event	12/08/2020
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 returned to the manufacturer for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during embolization of an avm with a liquid embolic, the scepter mini would not deflate and then could not be removed from the superior cerebellar artery (sca).During an attempt to remove the scepter with a snare device, the balloon detached from the catheter in the sca.The proximal segment of the sca became occluded and cerebral infarction developed, leading to brainstem compression and hydrocephalus.Ventricular drainage, avm removal, and external decompression were performed.
Additional Manufacturer Narrative
The returned device was severely damaged.The balloon is ruptured and detached, and the lumen is torn; therefore it is not possible to perform functional testing for balloon inflation.The alleged complaint cannot be confirmed.

• Brand Name: SCEPTER MINI
• Common Device Name: VASCULAR CLAMP
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11143923
• Report Number: 2032493-2021-00007
• Device Sequence Number: 3950220
• Product Code: MJN
• UDI-Device Identifier: 00842429106563
• UDI-Public: (01)00842429106563(11)200109(17)201231(10)2001091MX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: BC0210M-US
• Device Lot Number: 2001091MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 60