MAUDE Adverse Event Report: MICROVENTION SCEPTER XC; OCCLUSION BALLOON CATHETER

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	10/04/2022
Type of Reportable Event	Malfunction
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 investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.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 during treatment using a scepter xc balloon, the balloon initially had difficulty priming during set up.When the balloon was inflated inside the patient, it ruptured.No patient injury or adverse reactions occurred.
Additional Manufacturer Narrative
Correction to b4 date of this report: the date 4 november 2023 is a typographical error.The correct date is 25 october 2022, and it is added to this report.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Correction g4: a correction is being submitted as the wrong date (b)(6), 2023 was identified in g4.The correct date should be stated as (b)(6), 2023.This error was found on march 22, 2023.
Additional Manufacturer Narrative
Correction: original device product code mjn is wrong.The correct device product code is dqy.The investigation of the returned balloon catheter found the hub occluded with material consistent with dried contrast from the device preparation.After bypassing the hub, the balloon was attempted to be inflated.However, the investigation found a rupture in the balloon resulting in a leak, which is consistent with the alleged product issue.Further investigation found a fibrous material consistent with cotton within the balloon at the site of the rupture; however, the investigation could not determine when the cotton material entered the balloon or what the cotton material originated from.The physical evaluation of the device could not identify the conditions or circumstances that led to the rupture, but the damage is consistent with the device experiencing forces over specification.The findings from this investigation have been communicated to quality.

• Brand Name: SCEPTER XC
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15756862
• Report Number: 2032493-2022-00514
• Device Sequence Number: 4370275
• Product Code: DQY
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)210917(17)240831(10)0000083037
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2022
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: BC0411XC
• Device Lot Number: 0000083037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 01/13/2023; 03/17/2023; 01/09/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/19/2023; 03/20/2023; 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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: Unknown