MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-3D-AV; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); Ruptured Aneurysm (4436)

Event Date 09/09/2019

Event Type  Injury  

Event Description

It was reported that during coiling procedure to treat a patient with subarachnoid hemorrhage (sah), small intra-procedural rupture occurred, which was controlled immediately with inflation of a balloon microcatheter.Reportedly, there was no change in vitals and no ongoing extravasation at the conclusion of the case and the event resolved without sequelae.

Manufacturer Narrative

Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination could not be performed as the part/lot number information was not available at the time this investigation was performed.Complaint system review: a search of the complaint handling system could not be performed to determine if other similar complaints exist for this batch number, because the batch number was not provided for the product on this complaint file.Investigation conclusion: the physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

Manufacturer Narrative

Additional information received indicating that the small intra-procedural rupture that occurred was aneurysm rupture that was controlled immediately with inflation of a balloon microcatheter.

• Brand Name: HYDROSOFT-3D-AV
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 18945913
• MDR Text Key: 338185139
• Report Number: 2032493-2024-00229
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female