MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C; ACCESS DEVICES

Model Number	BC0410C-ID-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device is reported available for return to the manufacturer for analysis.At this time the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies balloon rupture potential complications associated with use of the device.
Event or Problem Description
It was reported that, the scepter-c was prepared without incident for post-dilatation of a flowdiverter.During the first inflation, the balloon was reported to burst in the flowdiverter.Another balloon was used for the post-dilation.The patient was reported to be okay.No patient harm or injury occurred.No intervention was performed.
Additional Manufacturer Narrative
Correction made to d8.Should be no.Item(s) returned: -scepter c item(s) not returned: - n/a the visual inspection of the device package showed no signs of damage as received.Further visual examination of the balloon catheter as received showed kink at 71.7 cm from the strain relief tip and under the strain relief.Upon further investigation the hub was bypassed manually by cutting the catheter distal to the hub and splicing into the inflation lumen using a tuohy borst adapter to test balloon inflation due to dried contrast.Balloon was confirmed burst, and blood was present inside of the balloon.
Additional Manufacturer Narrative
Added code, 24- cause traced to intentional off-label, unapproved or contraindicated use.
Event or Problem Description
See h10.

• Brand Name: SCEPTER C
• Common Device Name: ACCESS DEVICES
• 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: 16959285
• Report Number: 2032493-2023-00738
• Device Sequence Number: 5238634
• Product Code: DQY
• UDI-Device Identifier: 00842429103388
• UDI-Public: (01)00842429103388(11)230106(17)251231(10)0000303394
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: BC0410C-ID-700
• Device Catalogue Number: BC0410C
• Device Lot Number: 0000303394
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 05/05/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/31/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Female