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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Perforation (2001); Pericardial Effusion (3271)
Event Date 03/12/2021
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the pericardial effusion and septal laceration requiring intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. A small pericardial effusion was noted prior to the procedure. One clip was implanted, reducing mr to <1. During removal of the steerable guide catheter (sgc), the pericardial effusion worsened. Pericardiocentesis was performed however the bleeding would not stop and transesophageal echocardiography (tee) showed a septal laceration. An occluder was implanted to treat the laceration and stop the bleeding. Three hours post procedure a hematoma was noted on the posterior septum. The patient remains stable and no treatment was performed at this time. 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 Key11614967
MDR Text Key243813108
Report Number2024168-2021-02736
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Catalogue NumberSGC0702
Device Lot Number01201U116
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 Received04/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2020
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: 04/05/2021 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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