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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 SGC0302
Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. All available information was investigated and the and the reported difficult to advance was confirmed due to the observed torn silicone valve of the steerable guide catheter (sgc). 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 based on the result of the returned device analysis, the reported difficulty advancing the clip delivery system (cds) into the sgc appears to be due to the observed torn sgc silicone valve. The torn silicone valve was likely due to the user technique of cds insertion/advancement. There is no indication of a product issue with respect to manufacture, design or labeling. The additional cds referenced is being filed under a separate medwatch report number.
 
Event Description
This is being filed to report the torn silicone valve noted on the returned steerable guide catheter. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The clip delivery system (cds) met resistance during advancement in the steerable guide catheter (sgc). The cds was advanced and an attempt was made to open the clip when it detached from the delivery catheter (dc) but still remained on the gripper lines. The cds was pulled back however the clip totally detached and remains in the iliac vein. One clip was able to be implanted, reducing mr to 1. No additional information was provided. Subsequent to the initially filed medwatch, return analysis noted the sgc silicone valve was torn. 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 Key9506152
MDR Text Key178336073
Report Number2024168-2019-14862
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/07/2020
Device Catalogue NumberSGC0302
Device Lot Number90507U107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2019
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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