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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 SGC0705
Device Problem Difficult or Delayed Positioning (1157)
Patient Problems Perforation (2001); Atrial Perforation (2511)
Event Date 11/17/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. 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 similar incident reported from this lot. Based on the available information, a cause the difficult or delayed positioning in anatomy could not be determined. A cause for the atrial perforation could not be determined. The reported patient effect of atrial perforation as listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures. The reported additional therapy/non-surgical treatment was a result of case-specific circumstances, as implantation of an occluder device was required to treat the atrial perforation. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is being filed to report the atrial septal defect requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. When inserting the steerable guide catheter (sgc) resistance was met therefore the sgc was removed and the atrial septum was dilated with a 8mm balloon. The sgc was able to advance without issue. One clip was implanted, reducing mr to <1. After removal of the sgc, a right to left shunt was noted. An amplatzer plug was used as treatment. There was no clinically significant delay in the procedure and no adverse patient sequela. 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 Key10969762
MDR Text Key220417291
Report Number2024168-2020-10284
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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
Type of Report Initial,Followup,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/20/2021
Device Catalogue NumberSGC0705
Device Lot Number00821U136
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/08/2020 Patient Sequence Number: 1
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