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U.S. Department of Health and Human Services

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

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MICROVENTION INC. SOFIA-5F-115CM STR; PERCUTANEOUS CATHETER Back to Search Results
Model Number DA5115ST
Device Problems Break (1069); Unraveled Material (1664)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2023
Event Type  malfunction  
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 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.
 
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.
 
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Brand Name
SOFIA-5F-115CM STR
Type of Device
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 Key17213945
MDR Text Key318084567
Report Number2032493-2023-00818
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00812636020082
UDI-Public(01)00812636020082(11)220616(17)250531(10)0000207827
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Model NumberDA5115ST
Device Catalogue NumberDA5115ST
Device Lot Number0000207827
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/07/2023
Initial Date FDA Received06/27/2023
Supplement Dates Manufacturer Received09/06/2023
Supplement Dates FDA Received09/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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