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

Model Number BC0210M

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  Injury  

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.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

It was reported that to treat a dura fistula, a scepter mini should be used in combination with squid liquid embolic.The preparation of the scepter went well.The squid could not be injected through the scepter.A little came out with greater pressure, but then no more.The treatment was stopped and postponed.Patient is doing well.

Manufacturer Narrative

Investigation conclusion: the investigation of the returned scepter mini found the guidewire port of the hub and distal end of the guidewire lumen occluded with material consistent with solidified squid liquid embolic.As squid was observed at the distal end of the device, the liquid embolic was able to be injected through the lumen; however, solidified squid occluding the guidewire lumen port of the hub and guidewire lumen is consistent with the catheter lumen not being coated correctly with dmso per the ifu.This condition causes the squid to react with the saline used to hydrate the device during preparation and solidify.

Event Description

Please see section h10 for device investigation.

• 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: 18785599
• MDR Text Key: 336283379
• Report Number: 2032493-2024-00164
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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: 0000440690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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?: Yes
• Date Device Manufactured: 10/19/2023
• 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
• Treatment: SQUID LIQUID EMBOLIC - BALT.
• Patient Outcome(s): Other