MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQGUIDE STEERABLE SHEATH; STEERABLE CATHETER

Model Number 900002

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Air Embolism (1697); ST Segment Elevation (2059)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: acqmap catheter.Sheath:sjm agilis nxt.Guidewire: 0.032"gw.(b)(6) 2018 therapy date.

Event Description

It was reported that normal insertion of the steerable sheath into the left heart chamber was performed.Approximately 10 minutes after introducing the mapping catheter into the sheath, the patient showed st-segment elevation and av block.Emergency pacing and medication stabilized the patient.Coronary angiography was performed and showed air emboli in the coronary arteries.After treatment for air embolism, the patient showed regular st-segment and left lab fully awake and responsive.Patient is currently doing fine with no additional complications, and is expected to be discharged within 2 days.

Manufacturer Narrative

The acqguide 12f steerable sheath was returned for investigation.Visual inspection of the sheath revealed no visible shaft damage and all measurements met specification.Additionally, acqmap catheter and introducer were returned for investigation and all measurements met specification.The sheath underwent mechanical testing.Steering showed it functioned properly.Pressure testing was performed without any device/accessory inserted across the sheath valve.No leakage was seen in this configuration.The returned catheter was inserted into the sheath's seal, per the ifu, and no leak was observed.Aspiration was performed using a syringe, per ifu, with the catheter advanced and withdrawn in multiple positions, and no air was seen.The valve was removed from sheath and measured.Measurements met manufacturing criteria.The root cause for the reported issue could not be determined.Review of the involved acqguide 12f steerable sheath lot history records did not reveal any nonconforming material records associated with the lot, and the lot was released meeting manufacturing criteria.Based on all information reported and analysis results, the event was determined to be not likely a result of a malfunction of the acm sheath.

Event Description

Patient fully recovered with no neurological abnormalities and was released from the hospital within 5 days.

• Brand Name: ACQGUIDE STEERABLE SHEATH
• Type of Device: STEERABLE CATHETER
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; carlsbad 92008
• Manufacturer (Section G): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer Contact: greg geissinger ; 2210 faraday ave; suite 100; carlsbad, CA 92008 ; 4422326128
• MDR Report Key: 7291109
• MDR Text Key: 100760165
• Report Number: 3012120746-2018-00001
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: 900002
• Device Catalogue Number: 900002
• Device Lot Number: 100086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 104