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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 Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. The device was returned and investigated. The steerable guide catheter (sgc) was noted to have a torn soft tip. 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 the tears appear to be related to the clip interacting with the guide soft tip or from the metal piece identified on the clip delivery system (cds). Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. The clip delivery system referenced is filed under mfr # 2024168-2019-13130.
 
Event Description
This is filed for a tear in the steerable guide catheter soft tip. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. One clip was implanted without issue. The second clip delivery system (cds) was advanced into the steerable guide catheter (sgc) with some resistance at the sgc hemostasis valve; however, the device was then able to advance. When steering down to the valve, there was some resistance noted when retracting the delivery catheter (dc) handle. On fluoroscopy, an unknown metal object was seen on the cds shaft when testing the clip lock; however, the procedure continued and the clip was deployed without issue. The cds and sgc were removed as a single unit, without resistance. At the back table, the cds was easily removed from the sgc. Upon removal, a scrape was noted, approximately 1 inch from the tip of the cds. A piece of metal was seen, towards the distal end of the sleeve. When the physician touched the metal, it easily came off. There was no adverse patient effect or a clinically significant delay in the procedure. Returned device analysis noted that the soft tip of the sgc was torn; however, all pieces were present. 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 Key9307573
MDR Text Key177224195
Report Number2024168-2019-13467
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 11/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/18/2020
Device Catalogue NumberSGC0301
Device Lot Number90719U228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2019
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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