• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0302
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Ischemia (1942)
Event Date 10/05/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. A review of the complaint history identified no other incidents reported from this lot. The reported patient effect of air emboli, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. All available information was investigated and the reported slippage of the sgc, device operates differently than expected, appears to be a result of user technique/procedural conditions. The reported leak/air ingress appears to be a secondary effect of the device slippage. The reported patient effect of air embolism appears to be a result of procedural conditions, while the reported ecg changes and ischemia were symptoms/cascading effects of the air embolism. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
 
Event Description
This is filed to report the suspected air embolism and air in the device. It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr). As the dilator was being retracted out of the steerable guide catheter (sgc), the sgc slipped back into the right atrium. Air was noted in the sgc hemostatic valve and was aspirated. A change in the electrocardiogram (ecg) was noted and an air embolism was suspected, but not found. The ecg returned to normal after a few seconds. The procedure continued with successful implantation of two mitraclips, reducing mr to trace. Post procedure, the patient was noted to be stable. There was no additional information provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key6974422
MDR Text Key90126685
Report Number2024168-2017-08425
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 10/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/11/2018
Device Catalogue NumberSGC0302
Device Lot Number70511U110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/24/2017 Patient Sequence Number: 1
-
-