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

Model Number	BC0410C-ID-700-AL
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part and lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was reported available for return but has not yet been received.Therefore, at this time, the product analysis could not be performed and the alleged product issue cannot be verified.If the device or additional new information is received, a supplemental report will be submitted.
Event or Problem Description
It was reported that during use in an unspecified embolization procedure, the balloon catheter would not deflate.The physician slowly pulled out the device from the patient without any injury.Reportedly, during preparation, the balloon tested successfully without any problem.
Additional Manufacturer Narrative
Additional information: d10 (date device returned), h10 (device evaluation).Investigation findings: items returned for investigation: scepter c.Items not returned for investigation: n/a.The balloon was returned deflated.The hub was returned intact with residual contrast.Attempts to inflate the balloon were unsuccessful; the balloon could not be injected with saline during the investigation due to contrast occluding the inflation lumen.However, after hydrating the balloon in preparation for inflation during the investigation, the balloon was found to have a rupture.Investigation conclusion: the investigation of the returned balloon catheter found the inflation lumen occluded with material consistent with dried contrast and the balloon ruptured.Due to the contrast occlusion and balloon rupture, this investigation could not inflate the balloon to further assess the alleged deflation issue described in the reported event and therefore, this complaint is considered non-verifiable.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.

• Brand Name: SCEPTER C
• 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 ; 7142378000
• MDR Report Key: 19823593
• Report Number: 2032493-2024-00573
• Device Sequence Number: 12929423
• Product Code: MJN
• UDI-Device Identifier: 00842429117545
• UDI-Public: (01)00842429117545(11)240209(17)270131(10)0000516937
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: BC0410C-ID-700-AL
• Device Lot Number: 0000516937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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 Sex: Unknown