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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 SGC0702
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 11/04/2021
Event Type  Injury  
Event Description
This is filed to report tissue damage. It was reported that this was a degenerative mitral regurgitation (mr) with a grade 4. It was noted restricted - posterior. The transseptal puncture was performed without issue; however, while advancing the steerable guide catheter (sgc), the wire flipped out of the left upper pulmonary vein and curved to the left ventricle. The sgc was retracted to the right side of the heart. After a second crossover with the transseptal catheter, a structure was observed under the transseptal puncture. Imaging of the structure was not quite clear; however, after trying to find out where this structure was coming from, it was determined that there was possible tissue damage at the septum. Additional treatment was not performed. No clips were implanted, and mr is 4. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information 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 that would have contributed to the reported event. Additionally, a review of the complaint history identified no other complaints from the lot. All available information was investigated and a cause for the reported difficult positioning with the steerable guide catheter (sgc) cannot be determined. The tissue injury appears to be related to the procedural circumstances. Tissue damage is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design or labeling.
 
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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 Key12871444
MDR Text Key281327734
Report Number2024168-2021-10803
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/04/2022
Device Catalogue NumberSGC0702
Device Lot Number10303U206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2021
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: 11/24/2021 Patient Sequence Number: 1
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