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

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	08/19/2024
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 analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that the physician were treating an aneurysm on the right ica.A coil embolization in remodeling technique was planned.A scepter xc 4-11 balloon was chosen for the procedure.The balloon was prepared and the tip was sealed by using the heat gun.The balloon was placed at the neck of the aneurysm.A coiling microcatheter was placed inside the aneurysm.After placing the two coils the microcatheter lost its position.The balloon was deflated and the coiling microcatheter repositioned.When the physician inflated the balloon again it was almost not visible.She removed the balloon from the patient and checked it.She found blood inside the balloon.The tip was sealed with the heat gun for a second time.The balloon was placed at the neck of the aneurysm.During the inflation the distal tip of the balloon burst.The balloon was exchanged to a new product.The examination was continued with good result.The patient is doing well.No injury caused by this issue.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned balloon catheter found the balloon ruptured at the distal end, which is consistent with the alleged product issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the rupture, but this condition is consistent with the device experiencing forces over specification due to over inflation.Attempting to seal the balloon with a heat gun twice during the procedure, as described in the reported event, could have additionally weakened the balloon membrane and contribute to the balloon rupture.

• Brand Name: BALLOON CATHETER
• Common Device Name: SCEPTER XC
• 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: 20501113
• Report Number: 2032493-2024-00772
• Device Sequence Number: 7471984
• Product Code: MJN
• UDI-Device Identifier: 00842429117583
• UDI-Public: (01)00842429117583(11)240304(17)270228(10)0000537463
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 0000537463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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: Male