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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

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ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 07/14/2022
Event Type  Injury  
Event Description
This is filed to report the atrial septal defect.It was reported that the initial mitraclip procedure was performed on (b)(6) 2022, to treat degenerative mitral regurgitation (mr) with a grade of 4.The transseptal puncture was suboptimal.One mitraclip was implanted successfully.A second clip was advanced and attempted to be placed at a2p2 lateral to the first clip.While adjusting the clip under the valve by 10 degrees, the clip became caught in the chords.The clip was unable to be unstuck and a grasp was attempted.The leaflet became stuck behind the gripper.Minor adjustments were made, and the grippers were cycled to become unstuck.An attempt was made to move back to the left atrium (la).However, due to the limited height of the transseptal puncture there was difficulty getting back to the la even with under straddling.It was suspected the clip was stuck in the chords due to lost height.A good grasp was obtained, and the clip was deployed.Two clips total were implanted reducing the mr to 1.When the steerable guide catheter was pulled across the septum it was noted that the septum was torn there was a large atrial septal defect (asd).The flow was left to right, so the asd was left untreated.There was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, the atrial perforation (asd/atrial septal defect) appears to be related to procedural conditions.Perforation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The minor injury/ illness / impairment was a result of case-specific circumstances, as no treatment was provided.There is no indication of a product issue with respect to manufacture, design or labeling.The mitraclip device referenced is filed under a separate medwatch report number.
 
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Brand Name
G4 STEERABLE GUIDING CATHETER
Type of Device
CATHETER, STEERABLE
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key15154173
MDR Text Key297187191
Report Number2024168-2022-08496
Device Sequence Number1
Product Code DRA
UDI-Device Identifier08717648231025
UDI-Public08717648231025
Combination Product (y/n)N
Reporter Country CodeCA
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 Physician
Type of Report Initial
Report Date 08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/17/2023
Device Model NumberN/A
Device Catalogue NumberSGC0701
Device Lot Number20216R747
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/14/2022
Initial Date FDA Received08/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
IMPLANTED MITRACLIP (X2)
Patient Outcome(s) Other;
Patient Age77 YR
Patient SexFemale
Patient Weight68 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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