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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
Model Number SGC0701
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.
 
Event Description
This is filed to report leak.It was reported that during preparation of a steerable guide catheter (sgc), the column would not hold fluid.The sgc was not used in the patient.The procedure continued with a new sgc.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
All available information was investigated and the reported leak was not confirmed during return device analysis as no issues were noted during testing.A review of the lot history record revealed no manufacturing nonconformities reported to this lot.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.A conclusive cause for the reported leak could not be determined in this complaint.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design or labeling.
 
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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
MDR Report Key10961059
MDR Text Key220240963
Report Number2024168-2020-10227
Device Sequence Number1
Product Code DRA
UDI-Device Identifier08717648231025
UDI-Public08717648231025
Combination Product (y/n)N
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00928U751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Date Manufacturer Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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