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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 04/22/2020
Event Type  malfunction  
Manufacturer Narrative
The device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the steerable guide catheter leak.It was reported that during preparation of the steerable guide catheter (sgc), the sgc, failed to hold column.The device was not used.There was no patient involvement and no clinically significant delay during the procedure.No additional information regarding this issue was provided.
 
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was reviewed and without the device to analyze, a cause for the reported leak/splash (loss of fluid column during prep) could not be determined.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 Key10063329
MDR Text Key191998951
Report Number2024168-2020-04342
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 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/05/2020
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number91106U134
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/22/2020
Initial Date FDA Received05/15/2020
Supplement Dates Manufacturer Received05/22/2020
Supplement Dates FDA Received06/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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