MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C; BALLOON CATHETER

Model Number	BC0415C-ID-700
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 analysis and the investigation is currently underway.A supplemental report will be submitted when investigation is completed.The instructions for use (ifu) includes this warning: during air-purging of catheter lumen, inject fluid slowly otherwise balloon may rupture.
Event or Problem Description
It was reported that the scepter balloon exhibited a rapid pressure loss and contrast leakage during an occlusion test prior to a carotid occlusion.There was no patient harm reported.The patient is released from the hospital.
Additional Manufacturer Narrative
Additional information: h10 (summary device evaluation).Summary device evaluation: the investigation of the returned scepter c found a pinhole when inflated, which was located at 0.0746in from the distal bond marker band.The visual inspection and physical evaluation of the device did not identify any other out-of-specification conditions that would have led to this pinhole.This condition and related root causes are mapped in the product's corresponding fmea.Controls in place are mapped to the manufacturing and quality procedures - these controls are validated/verified per procedure.Occurrence rates are within the expected probability per the fmea.

• Brand Name: SCEPTER C
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13923624
• Report Number: 2032493-2022-00115
• Device Sequence Number: 6251037
• Product Code: MJN
• UDI-Device Identifier: 00842429103395
• UDI-Public: (01)00842429103395(11)210426(17)240331(10)210426565
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 03/31/2024
• Device Model Number: BC0415C-ID-700
• Device Catalogue Number: BC0415C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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
• Patient Sex: Male