MAUDE Adverse Event Report: MICROVENTION INC. SOFIA-5F-115CM STR; PERCUTANEOUS CATHETER

Model Number	DA5115ST
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
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 stated to be available for return to the manufacturer for evaluation, but has not yet been returned.However, procedural imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that after the sofia was inserted using a glidesheath and microcatheter, onyx was injected.Immediately after injection, the physician then noticed the distal end of the sofia appeared to be unwinding.The entire system was removed.After removal, the catheter¿s internal coiling was hanging out at the end.The procedure was completed.There was no adverse impact to the patient.
Additional Manufacturer Narrative
Two radiographic images were provided for review.Image 1 is a left ica ap oblique roadmap.It shows the ica at the skull base all the way to the ica terminus and bifurcation.A catheter (presumably the sofia described in the complaint) is positioned at the proximal petrous segment.Pulsation motion artifact is seen at the tip of the catheter.Image 2 is a roadmap taken during onyx or contrast injection into an avm.Part of the nidus contains onyx which was injected prior to the roadmap and is subtracted out.Either onyx or contrast is being injected into the nidus of the avm via a microcatheter.The tip of the sofia is still in the proximal petrous segment.The cause of the problem described with the tip of the sofia is not seen on these images.However, the investigation of the returned sofia catheter found a coil dislodged from the interior of the catheter at approximately 11-12cm from the distal end, and the dislodged coil was found protruding from the distal tip, 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 dislodged coil, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: SOFIA-5F-115CM STR
• Common Device Name: PERCUTANEOUS CATHETER
• 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: 17213945
• Report Number: 2032493-2023-00818
• Device Sequence Number: 19588713
• Product Code: DQO
• UDI-Device Identifier: 00812636020082
• UDI-Public: (01)00812636020082(11)220616(17)250531(10)0000207827
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 05/31/2025
• Device Model Number: DA5115ST
• Device Catalogue Number: DA5115ST
• Device Lot Number: 0000207827
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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