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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 SGC0702
Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the steerable guide catheter (sgc) soft tip tear. It was reported the mitraclip procedure was performed to treat grade 4 degenerative mitral regurgitation. The vessel was dilated with a 20f dilator. When inserting the steerable guide catheter (sgc) ensemble over the stiff wire into the vessel, resistance was felt after approximately 3-4 cm. The sgc was removed, and the sgc soft tip was noted to be torn. The vessel was dilated again and a new sgc was used without issue. One clip was implanted, reducing mr to <1. There were no adverse patient effects and no clinically significant delay in the procedure.
 
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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 Key11780412
MDR Text Key262959833
Report Number2024168-2021-03823
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/18/2021
Device Catalogue NumberSGC0702
Device Lot Number01118U323
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2020
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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