MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC; OCCLUSION BALLOON CATHETER, PRODUCT CODE: MJN

Model Number	BC0411XC-ID-700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
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 was returned to the manufacturer for analysis.The investigation is currently ongoing.The instruction for use (ifu) include the warnings: do not exceed the maximum recommended inflation volume as balloon rupture may occur.Excessive pressure higher than 300 psi (2069kpa) may cause leakage or rupture of the balloon catheter working lumen.
Event or Problem Description
It was reported that a scepter xc balloon catheter burst during the procedure.It was removed and replaced with another balloon catheter and the procedure was successfully completed.There was no reported injury or intervention.
Additional Manufacturer Narrative
The investigation of the returned balloon catheter system found a rupture in the balloon and heavy delamination of the distal balloon bond, which is consistent with the alleged product issue.A rupture in the balloon and delamination of the distal balloon bond are damages consistent with the balloon being over-inflated during the procedure and bursting, as described in the reported complaint.The physician evaluation of the device could not identify the condition or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: SCEPTER XC
• Common Device Name: OCCLUSION BALLOON CATHETER, PRODUCT CODE: MJN
• 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: 13805913
• Report Number: 2032493-2022-00094
• Device Sequence Number: 20081880
• Product Code: MJN
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)210920(17)240831(10)0000084587
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 08/31/2024
• Device Model Number: BC0411XC-ID-700
• Device Lot Number: 0000084587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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 Age: 10 YR
• Patient Sex: Male