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

Model Number	BC0210M-US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
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 analysis is currently underway.
Event or Problem Description
It was reported that during an avm embolization case, tortuous anatomy was encountered and a scepter mini balloon catheter would not advance further, stopped at a horseshoe-shaped turn.It was decided to deploy liquid embolic at that point instead of a more distal position.After embolization, the scepter mini was withdrawn and it appeared that the braiding in the shaft had pulled apart.The distal part of the scepter was stuck outside the distal end of the intermediate catheter; the other portion of it was within the intermediate catheter.The distal portion of the scepter was snared after multiple attempts and was withdrawn in its entirety along with the intermediate catheter.The procedure's completion was delayed between two and three hours.The patient was reported to be "ok" after the case.
Event or Problem Description
It was reported that during an avm embolization case, tortuous anatomy was encountered and a scepter mini balloon catheter would not advance further, stopped at a horseshoe-shaped turn.It was decided to deploy liquid embolic at that point instead of a more distal position.After embolization, the scepter mini was withdrawn and it appeared that the braiding in the shaft had pulled apart.The distal part of the scepter was stuck outside the distal end of the intermediate catheter; the other portion of it was within the intermediate catheter.The distal portion of the scepter was snared after multiple attempts and was withdrawn in its entirety along with the intermediate catheter.The procedure's completion was delayed between two and three hours.The patient was reported to be "ok" after the case.
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 analysis is currently underway.
Additional Manufacturer Narrative
The returned scepter balloon was found to be kinked and damaged in multiple locations along the length of the device.The device was fractured with the braiding of the catheter coming apart as described in the complaint.A black substance was found on the balloon, which is consistent in appearance with the onyx referenced.The damage to the device is consistent with the distal tip of the balloon catheter becoming entrapped in the onyx cast, followed by retraction force that exceeded the strength of the scepter, resulting in the damage seen.

• 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: 13488244
• Report Number: 2032493-2022-00049
• Device Sequence Number: 5210640
• Product Code: MJN
• UDI-Device Identifier: 00842429106563
• UDI-Public: (01)00842429106563(11)210614(17)240531(10)210614138
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 05/31/2024
• Device Model Number: BC0210M-US
• Device Lot Number: 210614138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown