MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problem Device Damaged by Another Device (2915)

Patient Problem Cardiac Arrest (1762)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the sgc was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report cardiac arrest.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing the mr to 1-2.During removal of the steerable guide catheter (sgc), the patient suffered a cardiac arrest.After removal of the sgc, it was noted that one of the pacemaker electrodes was moved out.In the physicians opinion, the manipulation of the sgc and heart morphology may have contributed to the cardiac arrest.The patient was stabilized with an electro-catheter and will remain hospitalized awaiting another interventional procedure to replace the electro catheter.One clip was implanted, reducing mr to 1-2.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.All available information was investigated, and the reported device causing damage to another device appears to be due to a combination of user technique of sgc retraction during the procedure, and the rotated heart and dilatation of cavities.The reported cardiac arrest was a cascading effect of the reported device causing damage to another device, as the patient experienced cardiac arrest immediately after the pacemaker electrode was dislodged by the sgc.The reported patient effect of cardiac arrest is listed in the mitraclip nt system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: the steerable guide catheter (sgc) had interacted with the pacemaker.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8170551
• MDR Text Key: 130533818
• Report Number: 2024168-2018-09764
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80925U257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention