MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER MINI; PERCUTANEOUS CATHETER

Model Number BC0210M

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the actual device part/lot number combination could not be performed as the lot number was not provided.The device was discarded by the user facility.Images and op reports were sought but were not provided for analysis.The event as described could not be confirmed.If further information is received at a later date, a supplemental report will be submitted.

Event Description

It was reported that a scepter mini was used in combination with a liquid embolic to perform an embolization of an avm.During the procedure, the physician noticed a blood pressure drop, which indicated a bleeding.It was suspected that the scepter may have been overinflated, which could have led to the bleeding.The patient was rushed to the or for neurosurgical clipping and removal of the avm.The patient was reported to be stable.

Event Description

It was reported that a scepter mini was used in combination with a liquid embolic to perform an embolization of an avm.During the procedure, the physician noticed a blood pressure drop, which indicated a bleeding.It was suspected that the scepter may have been overinflated, which could have led to the bleeding.The patient was rushed to the or for neurosurgical clipping and removal of the avm.The patient was reported to be stable.

Manufacturer Narrative

Items returned: n/a.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 this 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.Ifu review (additional information can be found in the ifu): potential complications potential complications include, but are not limited to vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.Exposure to angiographic and fluoroscopic x-radiation presents potential risks of alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia that increase in probability as procedure time and number of procedures increase.Precautions after balloon preparation for use and prior to use, re-inflate to nominal volume and inspect for any irregularities or damage.Do not use if any inconsistencies are observed.The balloon catheter has a lubricious surface and should be hydrated for at least 30 seconds prior to use.Once the balloon catheter is hydrated, do not allow it to dry.Exercise care in handling the balloon catheter to reduce the chance of accidental damage.With the exception of dimethyl sulfoxide (dmso), use of other organic solvents may damage the balloon catheter and/or coating on the surface.Take precaution when manipulating the balloon catheter in tortuous vasculature to avoid damage.Avoid advancement or withdrawal against resistance until the cause of resistance is determined.Presence of calcifications, irregularities or existing devices may damage the balloon catheter and potentially affect its insertion or removal.Excessive torque applied to the syringe might result in damage to the scepter hub assembly.Directions for use (refer to diagram for reference) 1.Attach a rotating hemostatic valve (rhv) to the guidewire lumen of the balloon catheter.Set up a continuous saline flush line and connect it to the sidearm of the rhv.2.Choose appropriate guiding or diagnostic catheter.Attach a rhv to the proximal hub of the guiding or diagnostic catheter.To prevent backflow of blood into the lumen of the catheter, connect the continuous saline flush line to the sidearm of the rhv.3.Open the rhv on the hub of the guiding or diagnostic catheter and introduce the balloon catheter/guidewire into the guiding catheter using the introducer sheath.Carefully advance the balloon catheter/guidewire to the guiding catheter distal tip.After the balloon catheter/guidewire reaches the tip of the guiding catheter, remove the introducer from the balloon catheter shaft by retracting the introducer from the rhv and peeling off the introducer.Advance the balloon catheter through the rhv.4.Advance the balloon catheter and guidewire to the desired location in the vasculature using fluoroscopic visualization.Carefully tighten the valve of the rhv around the balloon catheter to prevent leakage from the rhv.The rhv should still allow for balloon catheter advancement after tightening.Warning: do not over-tighten the rhv around the balloon catheter.Over-tightening could delay balloon inflation and deflation.Warning: do not advance the balloon catheter or guidewire against resistance.If resistance is felt, assess the source of resistance using fluoroscopic means.5.Attach a 2-way stopcock to a high-resolution syringe filled with appropriate contrast solution.Prime the 2-way stopcock so that no air is present.Slowly inflate the balloon to the recommended volume to achieve the desired diameter as described in table 3.Warning: do not exceed the maximum recommended inflation volume as balloon rupture may occur.Warning: always inflate and deflate the balloon while visualizing under fluoroscopy to ensure patient safety.6.After inflation, lock the stopcock if desired.7.If desired, remove the guidewire from the balloon catheter and prepare per the respective diagnostic or therapeutic agent ifu(s) for delivery through the guidewire lumen.Warning: excessive pressure higher than 700 psi (4826kpa, 47.6atm) may cause leakage or rupture of the guidewire lumen.8.When deflating balloon, use fluoroscopy to ensure complete deflation prior to removal.See table 1 for respective deflation times.After procedure is complete, slowly remove the balloon catheter and guidewire.The reported event is non-verifiable.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.

• Brand Name: SCEPTER MINI
• 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 Key: 17292788
• MDR Text Key: 318832770
• Report Number: 2032493-2023-00830
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BC0210M
• Device Lot 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: 07/24/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention