MAUDE Adverse Event Report: MICROVENTION INC. BALLOON CATHETER; CATHETER INTRAVASCULAR OCCLUDING TEMPORARY

Model Number	BC0415C-ID-700
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a scepter balloon catheter did not deflate during a coil embolization procedure.The device was removed in an inflated state.The procedure was completed with another device and the patient was reported to be stable.There was no injury or intervention.
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 stated to be available for return to the manufacturer for evaluation but it has not yet been returned to the manufacturer.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be be performed, the results of which will be provided in a supplemental mdr.
Additional Manufacturer Narrative
Items returned for investigation: scepter c.Items not returned for investigation: n/a.The balloon was returned deflated.Residual contrast was observed occluding the hub.The distal end of the catheter shaft was observed to be flattened.The inflation port was injected with dyed saline, but the balloon could not be inflated.The occluded hub was bypassed, but the balloon still could not be inflated with saline during the investigation due to the flattened section.The investigation of the returned balloon catheter found a flattened section at the distal end of the catheter shaft, the hub occluded with material consistent with contrast material, and the balloon deflated.The flattened section of the device may have caused or contributed to the alleged deflation issue if present at the time of the reported event; however, this investigation was unable to inflate the balloon during functional testing due to the flattened section to further assess the deflation time of the balloon 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 damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
It was reported that a scepter balloon catheter did not deflate during a coil embolization procedure.The device was removed in an inflated state.The procedure was completed with another device and the patient was reported to be stable.There was no injury or intervention.

• Brand Name: BALLOON CATHETER
• 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: 19662926
• Report Number: 2032493-2024-00511
• Device Sequence Number: 6737355
• Product Code: MJN
• UDI-Device Identifier: 00842429103395
• UDI-Public: (01)00842429103395(11)230309(17)260228(10)0000332948
• 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): 09/04/2024

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 Expiration Date: 02/28/2026
• Device Model Number: BC0415C-ID-700
• Device Lot Number: 0000332948
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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