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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 Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
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 being filed to report that during preparation of the steerable guide catheter the bottom of the hemostatic valve leaked.It was reported that during preparation of the steerable guide catheter (sgc), when flushing the dilator, the bottom of the hemostatic valve leaked.In attempt to avoid risk of an air embolism, the device was not used, a replacement sgc was used.There was no clinically significant delay during the procedure.No additional information was provided.
 
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 being filed to report that during preparation of the steerable guide catheter the bottom of the hemostatic valve leaked.It was reported that during preparation of the steerable guide catheter (sgc), when flushing the dilator, the bottom of the hemostatic valve leaked.In attempt to avoid risk of an air embolism, the device was not used, a replacement sgc was used.There was no clinically significant delay during the procedure.No additional information was provided.
 
Event Description
It was reported that during preparation of the steerable guide catheter (sgc), when flushing the dilator, the bottom of the hemostatic valve leaked.In attempt to avoid risk of an air embolism, the device was not used, a replacement sgc was used.There was no clinically significant delay during the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.All available information was investigated, and the reported leak was confirmed via returned device analysis and observed the crack on the bottom of the rotating hemostatic valve (rhv) dilator.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 complaints reported from this lot.The investigation determined the reported leak/splash appears to be related to the crack on the rhv dilator.The crack on the rhv dilator appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
 
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Brand Name
G4 STEERABLE GUIDING CATHETER
Type of Device
CATHETER, 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 Key13602699
MDR Text Key286150361
Report Number2024168-2022-02024
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 Physician
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/22/2022
Device Catalogue NumberSGC0702
Device Lot Number10723R129
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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