• 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 Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2017
Event Type  malfunction  
Event Description
Subsequent, to the initial 30-day medwatch report, it was reported that the steerable guide catheter (sgc) performed as intended. There was no steering issue or difficulty noted during removal of the sgc. This event has been reported; therefore, it will remain reportable. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Subsequent, to the initial 30-day medwatch report, it was reported that the steerable guide catheter (sgc) performed as intended. There was no steering issue or difficulty noted during removal of the sgc. This event has been reported; therefore, it will remain reportable. No further investigation is required.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the clip was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system referenced in is filed under a separate medwatch report number.
 
Event Description
This is filed to report the difficult removal. It was reported that on (b)(6) 2017, the patient, with functional mitral regurgitation (mr), underwent a mitraclip procedure. Patient anatomy included a large aorta and a small left atrium. The steerable guide catheter (sgc) was advanced into the patient anatomy without issue. Due to the patient anatomy, some visualization difficulties were noted. However, when the clip delivery system (cds) was advanced, a steering issue was noted. The cds was not properly aligned during insertion and when the m knob was applied, the device did not respond appropriately. It was decided to remove the cds in order to properly align, but during retraction, one of the clip arms became stuck between the sgc and the grippers. Troubleshooting maneuvers were performed in order to release the clip arm from the sgc, but troubleshooting was unsuccessful. The physician made the decision to retract the sgc with the clip remaining stuck on the sgc. This was performed slowly in order to not injure the patient. After removal, the decision was made to use a new sgc and a new cds. A new vessel access site was performed in the right femoral artery. The clip was implanted in the central portion of the anterior 2/posterior 2 (a2/p2) leaflet segment and the mr was reduced from grade 4+ to grade 1+. No additional information was 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
MDR Report Key7173426
MDR Text Key284202543
Report Number2024168-2018-00170
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,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0302
Device Lot Number70922U134
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/08/2018 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
-
-