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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA DISTAL ACCESS CATHETER (DA5125ST) PERCUTANEOUS CATHETER/ DIAGNOSTIC INTRAVASCULAR CATHETER

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MICROVENTION, INC. SOFIA DISTAL ACCESS CATHETER (DA5125ST) PERCUTANEOUS CATHETER/ DIAGNOSTIC INTRAVASCULAR CATHETER Back to Search Results
Model Number DA5125ST
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Coma (2417)
Event Date 04/01/2021
Event Type  Injury  
Manufacturer Narrative
Telephone number: (b)(6). 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. Investigation is ongoing.
 
Event Description
It was reported that treatment of the posterior fossa a scepter mini balloon catheter was tracked through a sofia 5f 125cm catheter to the right vertebral artery and posterior inferior cerebellar artery (pica) bifurcation. The scepter mini was inflated in the pica. Onyx was injected through the scepter mini to embolize a tumor of the posterior fossa. The onyx refluxed around the balloon to a level 2mm proximal to the scepter mini's proximal balloon marker. The scepter mini was pulled out of the cast but the scepter mini could not be withdrawn from the onyx cast. The sofia 5f was tracked into the pica to support the removal of the scepter mini, however both became irremovable and the patient was moved to neurosurgery for assistance with removal of the scepter mini and sofia and the planned excision of the tumor was brought forward to be carried out during the craniotomy. Patient had surgical intervention performed by craniotomy in neurosurgery to remove the catheters. The patient was comatose for 3 days post neurosurgical excision of their tumor post-embolization. As of the (b)(6), 11 days post op, the patient is weak and has not fully woken up.
 
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Brand NameSOFIA DISTAL ACCESS CATHETER (DA5125ST)
Type of DevicePERCUTANEOUS CATHETER/ DIAGNOSTIC INTRAVASCULAR CATHETER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
MDR Report Key11823283
MDR Text Key250600219
Report Number2032493-2021-00205
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00810170019234
UDI-Public(01)00810170019234(11)201112(17)231031(10)20111252R
Combination Product (y/n)N
PMA/PMN Number
K131482
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDA5125ST
Device Catalogue NumberDA5125ST
Device Lot Number20111252R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/13/2021 Patient Sequence Number: 1
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