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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 STEERABLE GUIDE CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR MITRACLIP G4 STEERABLE GUIDE CATHETER CATHETER, STEERABLE Back to Search Results
Model Number SGC0701
Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  malfunction  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The cds-ntw referenced was filed under mfr# 2024168-2020-00552-00.
 
Event Description
This is filed to report the torn soft tip observed on the returned steerable guide catheter (sgc) which was used with the first clip delivery system (cds). It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr). The sgc and the ntw cds were advanced to the left atrium via right groin access without issue. There was difficulty opening the clip, but the clip popped open and the clip had detached from the cds. It was decided to remove the cds with the clip. The clip was retracted to the sgc tip via the lock line. Left groin access was then obtained and a guide wire was advanced across the septum next to the sgc. A 14 french balloon dilatation catheter (bdc) was advanced to the septum and dilated the septum to allow for passage of the open clip. The bdc was removed and the sgc was retracted with the open clip across the septum into the right atrium and down to the groin. A new sgc and new cds were advanced to the left atrium via the left groin access. The mitral valve was treated and mr was reduced to grade 1 with the single clip. The atrial septal defect was closed with a septal occluder. The first sgc and clip were then fully removed from the patient via the right groin. Pressure was applied and the access sites were sutured. The patient is doing great. The following day, the patient was discharged home from the hospital with mr grade 1. No additional information was provided.
 
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Brand NameMITRACLIP G4 STEERABLE GUIDE CATHETER
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9639834
MDR Text Key177379574
Report Number2024168-2020-00958
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/23/2020
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number91024U222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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