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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE Back to Search Results
Model Number SGC0701
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/19/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The additional device referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report torn tip. It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4. The clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed. However, mr did not change. A second cds (00818u214) was advanced to the mitral valve, and the clip was grasped the leaflets fine. However, the mean pressure gradient increased to 8mmhg. Therefore, the clip un-grasped the leaflets to remove the cds from the patient. But, when the clip was retracted back into the tip of the steerable guide catheter (sgc), the clip became stuck at the guide tip. It was noted that the physician inadvertently did not lock the clip during removal of the cds. The cds and sgc were both retracted back to the groin and the sgc was removed. However, the tip of the sgc became torn and the clip became stuck in tissue. Due to the clip not being locked, the clip was inverted, but the mandrel broke and the clip became detached, but remained attached to the gripper and lock lines. Tissue damage was observed resulting a clinically significant delay in the procedure. Therefore, the patient remained hospitalized longer due to the clip was removed through a surgical-cutdown and the tissue damage was treated surgically. The first clip remains stable on the leaflets. One clip was implanted, and mr is 4. No additional information was provided.
 
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Brand NameG4 STEERABLE GUIDING 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 Key11499015
MDR Text Key242175342
Report Number2024168-2021-02074
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 05/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/16/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01116U417
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 Received04/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2020
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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