• 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 Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). All available information was investigated and the reported steerable guide catheter (sgc) torn soft tip was confirmed. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated and the reported clip getting caught on the guide tip, resulting in the identified tears in the soft tip appears to be related to user technique due to the physician retracting the clip delivery system (cds) quickly. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not complete. A follow up report will be submitted with all relevant information. The clip delivery system referenced is filed under a separate manufacturing report number.
 
Event Description
This report is filed for tears in the steerable guide catheter tip. It was reported that this was a mitraclip procedure treating functional mitral regurgitation (mr) grade 4. The clip delivery system (cds) was advanced to the left atrium and was steered down into position. Following, the on attempt to open the clip, the clip was unable to open. Troubleshooting maneuvers were performed, however, this clip would still not open. An attempt was made to quickly remove the cds; however, during removal, the clip was hanging at the tip of the steerable guide catheter (sgc). The clip was unable to be freed from the sgc tip and was still unable to open. The cds and sgc were removed as a single unit at the groin site via a surgical procedure. Following, sgc tip tears were noted. Reportedly, the tears were due to the clip attachment to the sgc tip. There was a delay reported; however, there were no associated clinical symptoms. The mr remined grade 4. Reportedly, the patient had no subsequent problems and another mitraclip procedure will be performed in 6-8 weeks. There was no additional information provided regarding this issue.
 
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 Key6926319
MDR Text Key248213086
Report Number2024168-2017-08013
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,Followup
Report Date 11/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/25/2018
Device Catalogue NumberSGC0302
Device Lot Number70424U307
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-