• 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 SGC0101
Device Problems Difficult to Insert (1316); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/02/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned and investigated. The reported difficult cds insertion through the hemostasis valve was confirmed. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no other incidents reported from this lot. The reported difficult to insert the cds into the sgc was due to a tear in the silicone valve within the hemostasis valve. The tear was observed at the neck of the luer causing the manufacturing slit on the silicone valve to shift. As a result there is no straight pathway for the clip to enter the slit; therefore, making it difficult for the cds to be inserted. A definitive cause for how and when the tear occurred could not be determined. It is possible that the user technique contributed to the user experience; however, this could not be confirmed. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
This event is filed for a tear in the silicone valve within the hemostasis valve, which has the potential to cause or contribute to patient injury. It was reported that the patient underwent a mitraclip procedure on (b)(6) 2016, to treat degenerative mitral regurgitation (mr) of grade 4. The steerable guide catheter (sgc) and clip delivery system (cds) were prepared for use per instructions for use. The clip introducer of the cds could not pass through the hemostasis valve of the sgc and the cds was set aside. The sgc was replaced with a new sgc. The same cds was used with the new sgc and no issues were noted. The clip was deployed and the mr was reduced to grade 1. There was no adverse patient effect and no clinically significant delay. No additional information was provided. This is being reported based on returned device analysis which revealed that the silicone valve was torn.
 
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 Key6034829
MDR Text Key57717692
Report Number2024168-2016-07020
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112239
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 10/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue NumberSGC0101
Device Lot Number60617U119
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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: 10/17/2016 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
-
-