MAUDE Adverse Event Report: MICROVENTION, INC SOFI C; PERCUTANEOUS CATHETER

Model Number	BC0410C-ID-700
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 not returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.
Event or Problem Description
It was reported that a balloon catheter did not deflate during use.It was removed without injury to the patient or intervention.
Additional Manufacturer Narrative
The device was received for evaluation.Investigation found kinks along the shaft of the catheter consistent with the alleged product issue.The physical evaluation of the device could not identify the circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.Kinks on the shaft would result in difficulty inflating/deflating the balloon.

• Brand Name: SOFI C
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11822502
• Report Number: 2032493-2021-00174
• Device Sequence Number: 4443463
• Product Code: DQY
• UDI-Device Identifier: 00842429103388
• UDI-Public: (01)00842429103388(11)210107(17)231231(10)210107521
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K131482
• 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): 05/07/2021

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: 12/31/2021
• Device Model Number: BC0410C-ID-700
• Device Lot Number: 210107521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2021
• 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: 73 YR
• Patient Sex: Male