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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 Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2021
Event Type  malfunction  
Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system referenced filed under a separate medwatch report number.
 
Event Description
This is filed to report a tear in the steerable guide catheter (sgc) soft tip. It was reported that the mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4. The steerable guide catheter (sgc) was inserted into the femoral vein but due to the heavily calcified vein, the physician had to use force to advance the sgc. Once the sgc had crossed the septum, it was noted that tip of the sgc looked abnormal. The sgc was removed. Outside the patient anatomy, the sgc soft tip was noted to be torn. It was confirmed there was no material left inside the patient anatomy. A new sgc was prepared and inserted with no issue. A clip delivery system (cds) was advanced to the mitral valve and grasping was performed but one of the gripper arms did not come down. Independent grasping was performed but with the same results. The cds was removed from the patient anatomy without issue. The cds was tested outside the patient anatomy and gripper arm came down slightly and then tested again and failed to drop. The gripper arm was not functioning properly. A second cds was advanced and grasping was performed but was difficult due to the coaptation gap of the leaflets. A good grasp was made but mr was not reduced significantly. The physician decided not to deploy the clip as additional attempts to reduce the mr could cause damage to the valve. Therefore, the cds was removed and the procedure was aborted. Mr remained at 4. There was no tissue damage noted. There was no adverse patient effect and no clinically significant delay in the procedure. 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 Key11237126
MDR Text Key230025332
Report Number2024168-2021-00649
Device Sequence Number1
Product Code DRA
UDI-Device Identifier08717648231025
UDI-Public08717648231025
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 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/27/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01027U229
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 Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2020
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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