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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 Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated and a definitive cause for the reported sgc leak (loss of fluid column during sgc preparation) could not be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling. The clip delivery system referenced is filed under a separate medwatch report number.
 
Event Description
This is being filed to report leak. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. A steerable guide catheter (sgc) was being prepped; however, loss of fluid column was observed. The sgc was re-prepped with a new stopcock, but there was still loss of fluid column. The sgc was not used in the patient, and the procedure continued with a new sgc. The first clip was successfully deployed. Then a second clip delivery system (cds) was advanced to the mitral valve; however, the clip became caught with the chordae during placement. Troubleshooting was performed, and the clip was freed. Then a chordal rupture was observed. The cds was retracted back, and the clip was re-positioned to be placed lateral to the first clip and the clip was deployed. The chordal rupture was left untreated two clips were implanted, reducing mr to 3. The patient is stable. There was no clinically significant delay in the procedure. 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 Key9203069
MDR Text Key173552375
Report Number2024168-2019-12693
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 10/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/20/2019
Device Catalogue NumberSGC0301
Device Lot Number81220U149
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 Received09/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2018
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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