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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 Difficult or Delayed Positioning (1157)
Patient Problems Cardiac Enzyme Elevation (1838); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)
Event Date 01/26/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. A review of lot-specific similar complaints revealed no indication of a lot-specific product quality issue. The reported patient effects of tissue damage, cardiac enzyme elevation, and embolism as listed in the instructions for use, mitraclip system gen 4, u. S. (ifu) are known complications associated with mitraclip procedures. Based on available information, the reported difficult or delayed positioning (anatomy) appears to be due to the thick septum (challenging patient anatomy). A cause for the reported patient effects of tissue damage and cardiac enzyme elevation could not be determined. The reported embolism appears to be a cascading effect of the tissue damage. The additional therapy/non-surgical treatment was the result of case-specific circumstances. There is no indication of product issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report tissue damage. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with an mr grade of 4. When crossing the septum with the steerable guiding catheter (sgc), resistance was felt due to the thick septum. After the sgc crossed the septum, the dilator and guide wire were retracted; the patient had st elevation. It was suspected tissue from the septum potentially dislodged causing a 95% occlusion in the artery. Stenting was performed for treatment, and the mitraclip procedure was aborted. No clips were implanted. Mr remains at 4. The patient recovered and was reported to be doing well. Another mitraclip procedure will be discussed for a future date. The physician is not exactly sure of the actual cause for st elevation and occlusion as the patient has a history of arterial occlusion and a pre-existing graft that has been stented a few times. However, the physician feels a suspected tissue dislodgement from the septum could be the cause. 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 Key11341211
MDR Text Key232323486
Report Number2024168-2021-01284
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
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00710U157
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 Received01/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2020
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: 02/17/2021 Patient Sequence Number: 1
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