MAUDE Adverse Event Report: ARDEN HILLS, MN WOVEN DIAGNOSTIC ELECTRODE CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number H3012005941

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

Patient Problems Cardiac Arrest (1762); Cardiogenic Shock (2262)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of historical trending and similar complaint trending for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id# 2134265-2018-01862, 2134265-2018-01863, and 2134265-2018-01864.It was reported cardiac arrest and cardiogenic shock occurred.Two intellamap orion mapping catheters, a dynamic xt steerable diagnostic catheter, and a woven diagnostic catheter were selected for use during a ventricular tachycardia ablation procedure.During ablation with another manufacturer¿s ablation catheter, the patient experienced cardiac arrest and cardiogenic shock.Multiple external defibrillations/shocks were administered, as well as advanced life support including cpr and medications.The patient ultimately received circulatory assist devices (a heart pump and extracorporeal membrane oxygenation (ecmo)) before being transferred from the ep lab.The ep staff later reported that the patient required vascular surgery the next day as a result of the ecmo device.The patient appeared to be stabilized but in critical condition.Noise with the orion catheters had been noted; however, there was no information alleging the noise caused or contributed to the complications.The orion catheters had been removed from the patient¿s body for two and a half hours prior to onset of the patient¿s complications.The dynamic xt was in the patient when the complications occurred, and the woven catheter was positioned in the right ventricle thorough out the procedure.The physician was uncertain as to the cause of the cardiac arrest and cariogenic shock, but commented that the patient was likely sicker than previously considered prior to the procedure.

• Brand Name: WOVEN DIAGNOSTIC ELECTRODE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• Manufacturer (Section G): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7316052
• MDR Text Key: 101588227
• Report Number: 2134265-2018-01976
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2018

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: Health Professional
• Device Model Number: H3012005941
• Device Catalogue Number: 200594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/06/2018
• 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
• Treatment: ABLATION CATHETER: BIOSENSE WEBSTER SF
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 66 YR