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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)
Event Date 07/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The mitraclip nt is filed under a separate medwatch report.
 
Event Description
This is filed to report the full cardiorespiratory arrest that occurred during the procedure. It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr). The steerable guide catheter was advanced across the interatrial septum when the patient went into cardiorespiratory arrest. Cardiopulmonary resuscitation was performed and the patient was successfully resuscitated. A coronary angiogram was performed, but was unable to identify a cause for the full arrest. The procedure continued and one mitraclip was successfully implanted. When the gripper line was being removed, the clip detached from the posterior leaflet (single leaflet device attachment was noted). A second mitraclip was implanted to stabilize the first clip, reducing mr to grade 1. Attention was then placed on the severe tricuspid regurgitation, but visualization was poor due to the tricuspid anatomy. Leaflet grasping was difficult due to a pacer wire that was adjacent to the septal leaflet. The mitraclip was unable to grasp two tricuspid leaflets simultaneously so the procedure was completed with zero clips on the tricuspid valve. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. The reported patient effects of cardiac arrest and respiratory failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceSTEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7783452
MDR Text Key117123347
Report Number2024168-2018-06256
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/14/2019
Device Catalogue NumberSGC0301
Device Lot Number80514U229
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/14/2018 Patient Sequence Number: 1
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