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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Event Date 10/29/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001. The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effects of pericardial effusion and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. Based on the information reviewed, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report the pericardial effusion. It was reported this was a mitraclip procedure to treat grade 4+ mixed mitral regurgitation (mr). When crossing the septum into the left atrium, the steerable guide catheter (sgc) was inadvertently advanced towards the left upper pulmonary vein. The procedure was continued and the mitraclip delivery system was advanced, the patient became bradycardic and hypotensive, requiring medication. A pericardial effusion was noted and pericardiocentesis was performed. The clip was deployed after pericardiocentesis and the symptoms resolved. The procedure was aborted, another clip may be implanted at a future date. Mr was reduced to 3-4. It is suspected the dilator/sgc caused the effusion when crossing the septum into the left atrium. No additional information was provided.
 
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Brand NameSTEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
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 Key9318793
MDR Text Key166936820
Report Number2024168-2019-13550
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
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 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date05/28/2020
Device Catalogue NumberSGC0301
Device Lot Number90529U127
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 Received10/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2019
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: 11/13/2019 Patient Sequence Number: 1
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