MAUDE Adverse Event Report: MICROVENTION, INC. CHAPERON GUIDING CATHETER; CATHETER, PERCUTANEOUS

Model Number	GC695M2VT
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in the intracranial stenosis surgery employing a guide catheter encountered a complication.The intermediate / middle catheter failed to pass through the distal end / tip of the guiding catheter during the procedure, resulting in the inability to complete the procedure.Another brand's long sheath was used as a replacement, but the intermediate / middle catheter still could not pass through during delivery.The patient was reported to be fine; postoperative recovery is good.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation found that the intermediate catheter used with the chaperon guide catheter during the procedure was returned crushed and kinked at multiple sections along the distal end.No damage or other anomaly was found with the returned chaperon guide catheter that would have caused or contributed to the reported complaint.The intermediate catheter was inserted into the chaperon during the investigation and the distal end of intermediate catheter got caught at the hub of the chaperon and was impossible to insert.The inner diameter of the chaperon guiding catheter measured at 1.79mm and the outer diameter at the distal end of intermediate catheter measured at 1.80mm.As the intermediate catheter could not be inserted into the chaperon, the investigation could not further assess the alleged advancement difficulty through the distal end of the chaperon lumen and therefore, this complaint is considered non-verifiable.Based on the investigation result, no anomaly was found in the manufacturing records or in the dimensions of the actual device.It was likely that the outer diameter at the distal end of the intermediate catheter was larger than the inner diameter of the chaperon guiding catheter, making it impossible to insert.
Event or Problem Description
A supplemental report is being submitted to report the investigation findings, see h11.

• Brand Name: CHAPERON GUIDING CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 22992921
• Report Number: 2032493-2025-90467
• Device Sequence Number: 9413696
• Product Code: DQY
• UDI-Device Identifier: 00810170013157
• UDI-Public: (01)00810170013157(11)000101(17)261130(10)231225
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082385
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GC695M2VT
• Device Lot Number: 231225
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown