MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	BC0411XC-ID-700-AL
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: patient undergoing further embolization of vertebrobasilar aneurysm.After preparation of the balloon in accordance with recommendations, the balloon was found to be porous and striated, and air entry was visualized while being used inside the patient.The patient is well after the procedure.
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 has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: patient undergoing further embolization of vertebrobasilar aneurysm.After preparation of the balloon in accordance with recommendations, the balloon was found to be porous and striated, and air entry was visualized while being used inside the patient.The patient is well after the procedure.Additional information received: there was no air inside the balloon, this one was a little bit stretched when they pull it back after it broke inside the patient with product of contrast and serum physiologic.When the balloon broke the physician just pull it back of the patient without damage.The patient went well and they performed the procedure with another balloon of the competitors.The physician is complaining about the ballon breakage without air.There is no image.
Additional Manufacturer Narrative
Items returned for investigation: scepter xc.The balloon was returned uninflated.Residual contrast was observed in the inflation port of the hub.No contrast was observed in the inflation lumen under x-ray.The balloon was submerged in water and no air was observed exiting the air purge channel or balloon during the attempted inflation.No liquid was able to enter the inflation lumen even after flushing the inflation port.The device was dissected and excess glue was observed on the guidewire lumen, resulting in an occlusion of the inflation lumen.The investigation of the returned scepter xc found the balloon uninflated and intact.The inflation port of the hub was observed to contain residual contrast material; however, no contrast was observed in the inflation lumen.Dissection of the device found excess glue uv glue on the guidewire lumen which sealed the inflation lumen.Due to the uv glue occluding the inflation lumen, the device would not have been capable of being inflated and/or purged of air as described in the reported event and therefore, this complaint is considered non-verifiable.Excess uv glue would have been introduced on the unit during the manufacturing process.Corrective action has been initiated to address the uv glue issue.

• Brand Name: SCEPTER XC
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: 20637512
• Report Number: 2032493-2024-00812
• Device Sequence Number: 7367099
• Product Code: MJN
• UDI-Device Identifier: 00842429117583
• UDI-Public: (01)00842429117583(11)240604(17)270531(10)0000615253
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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 Model Number: BC0411XC-ID-700-AL
• Device Lot Number: 0000615253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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: 55 YR
• Patient Sex: Unknown