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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 Problems Crack (1135); Difficult to Flush (1251); Loose or Intermittent Connection (1371); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 09/04/2020
Event Type  malfunction  
Manufacturer Narrative
All information was investigated and the reported loose or intermittent connection, difficulty/inability to flush and device contamination with chemical or other material was confirmed via returned device analysis. The investigation determined that the reported loose flush port connection, difficulty/inability to flush and obstruction inside the flush port is the result of the observed flush port contamination with plastic piece. The reported crack on the luer was likely due to the clear plastic inside the luer making it appear to be a crack. The broken plastic piece was sent to the materials characterization lab for chemical analysis. Results indicate the material is comparable to the sample 3 way plastic stopcock. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. Additionally, a review of the complaint history identified no other complaints from the lot. The investigation identified the contamination of the luer with a plastic piece as a potential product issue. The issue is being addressed per internal operating procedures. Abbott will continue to trend the performance of these devices.
 
Event Description
This is filed to report the difficulty flushing the device. It was reported that during preparation of the steerable guide catheter, the side port looked cracked and the physician could not hook the 3-way stopcock and there was difficulty flushing the device as some obstruction was noted. There was no patient involvement and no clinically significant delay in the procedure. No additional information was provided.
 
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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 Key10771057
MDR Text Key214133419
Report Number2024168-2020-09105
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number00623U120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2020
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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