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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 Difficult to Insert (1316); Failure to Advance (2524); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
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 other incidents reported from this lot. Based on the information reviewed, the reported difficult to insert and failure to advance the steerable guide catheter (sgc) appear to be due to challenging patient anatomy. The reported torn soft tip appears to be a result of the reported difficult to insert and failure to advance. There is no indication of a product issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report a tear in the steerable guide catheter (sgc) soft tip. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) 4+. During insertion of the steerable guide catheter (sgc), there was difficulty and due to the tortuosity at the groin level, the sgc was not able to advance past the iliac artery. When the sgc was retracted, the soft tip was noted to be torn. Therefore, a new sgc was used successfully in the procedure. Two clips implanted, reducing mr to 1-2. There was no adverse patient effect 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 Key11878346
MDR Text Key252705296
Report Number2024168-2021-04383
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 distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/21/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10122U256
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2021
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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