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	02/22/2022
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 returned to the manufacturer for evaluation.The analysis is currently underway.Additional details on the procedure and patient status are being sought and a supplemental report will be submitted if those details are obtained.
Event or Problem Description
It was reported that during an avf treatment, a scepter mini balloon catheter was used to deliver liquid embolic.Reflux of the liquid embolic was observed.The balloon catheter was difficult to remove and broke into two segments.There was no reported harm to the patient and no reported intervention.
Additional Manufacturer Narrative
The investigation of the returned balloon catheter system found the device broken at 145cm from the proximal end, which is consistent with the alleged product issue.Reflux was observed during the procedure, as stated in the reported complaint.Reflux is the embolic substance (onyx) filling the intended target site, and then overfilling over the tip of the scepter.If there is too much reflux, the catheter can become trapped in the embolic cast.The separation of the coils and the elongation of the material around the coils is consistent with the distal end becoming caught/lodged in the embolic cast during removal and breaking due to experiencing retraction forces over specification as the device was stuck.However, the distal section of the catheter that includes the balloon was not returned for evaluation and therefore, the investigation could not examine this portion of the device to determine what caused or contributed to the reported complaint.

• 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: 13895620
• Report Number: 2032493-2022-00106
• Device Sequence Number: 4240449
• Product Code: MJN
• UDI-Device Identifier: 00842429106563
• UDI-Public: (01)00842429106563(11)210922(17)240831(10)0000064396
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: BC0210M-US
• Device Lot Number: 0000064396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2021
• 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: Male