• 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 SGC0301
Device Problem Naturally Worn (2988)
Patient Problem Mitral Regurgitation (1964)
Event Date 10/25/2017
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 evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. The reported patient effect of cardiac perforation (atrial perforation), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. Based on the information reviewed, the reported patient effect of atrial perforation appears to be related to patient morphology/pathology due to the floppy septum and there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report the torn septum. It was reported that on (b)(6) 2016 one mitraclip was implanted in the patient with degenerative mitral regurgitation (mr) reducing mr from grade 4 to 1. On (b)(6) 2017 a second mitraclip procedure was performed for recurrent mr grade 4+. The original mitraclip was stable and attached to both leaflets. At the re-clip procedure, during insertion of the steerable guide catheter (sgc) through the fossa ovalis of the floppy septum, the fossa ovalis became torn resulting in inadequate support of the sgc. There was difficulty steering to the valve because of the torn septum, but there were no device issues and one mitraclip was successfully implanted, reducing mr was reduced to grade 2+. 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 Key7025468
MDR Text Key91898425
Report Number2024168-2017-08917
Device Sequence Number1
Product Code DRA
UDI-Device Identifier08717648216824
UDI-Public08717648216824
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/18/2018
Device Catalogue NumberSGC0301
Device Lot Number70517U149
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 Received10/25/2017
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: 11/13/2017 Patient Sequence Number: 1
-
-