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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 06/27/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period. The customer reported the sgc was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system referenced is being filed under a separate medwatch report number.
 
Event Description
This is being filed to report the sgc soft tip became torn when the clip got caught during removal. It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with grade of 4. During the procedure, visibility was bad. The clip delivery system (cds) was advanced to the mitral valve but visibility was bad due to the transseptal puncture location and equipment and it was decided to redo the transseptal puncture. Therefore, it was decided to remove the cds. During removal of the cds, the clip became stuck with the steerable guide catheter (sgc) tip; therefore, both devices were removed from the patient anatomy together. Outside the patient anatomy it was noted that the sgc soft tip became torn. A new sgc and cds were used to successfully reducing mr to 1. There was no adverse patient effect and 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
connie speck
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8807716
MDR Text Key151625208
Report Number2024168-2019-10189
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,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2020
Device Catalogue NumberSGC0301
Device Lot Number90313U257
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 Received08/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2019
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: 07/19/2019 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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