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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE Back to Search Results
Catalog Number SGC0705
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2021
Event Type  malfunction  
Event Description
This is being filed to report the tear in the sgc and difficulty removing the cds. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. One clip was successfully implanted. During insertion of the second clip delivery system (cds) the device was miskeyed; therefore the decision was made to remove the cds; however the clip became caught on the tip of the steerable guide catheter (sgc). Troubleshooting was performed and the cds was able to be removed however the sgc tip was torn. Another clip was successfully implanted, reducing mr to 2. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional device is filed under a separate medwatch report number.
 
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Brand NameG4 STEERABLE GUIDING CATHETER
Type of DeviceCATHETER, STEERABLE
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 Key13223967
MDR Text Key283762745
Report Number2024168-2022-00358
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/10/2022
Device Catalogue NumberSGC0705
Device Lot Number10510R147
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2021
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: 01/11/2022 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
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