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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
Model Number SGC0301
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated and the reported soft tip tear appears to be related to the procedural conditions of the clip becoming caught on the steerable guide catheter soft tip. There is no indication of a product 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 filed to report the steerable guide catheter soft tip tear. It was reported that this was a mitraclip procedure performed to treat grade 4 mixed mitral regurgitation (mr). Imaging was challenging. The steerable guide catheter (sgc) was positioned and the clip delivery system (cds) was advanced through the sgc. The cds was being repositioned and was retracted to the sgc, but got caught on the sgc soft tip and tore it. The devices were removed and a new sgc and cds were used. One clip was implanted, reducing mr to 1+. There was no adverse patient effect or a clinically significant delay during the procedure. No additional information was provided regarding this issue.
 
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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 Key9757604
MDR Text Key181160054
Report Number2024168-2020-01786
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 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number90710U111
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 Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2019
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: 02/26/2020 Patient Sequence Number: 1
Treatment
MITRACLIP DELIVERY SYSTEM
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