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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 01/25/2022
Event Type  Injury  
Event Description
Patient id: (b)(6). This is filed for pericardial effusion, requiring intervention. It was reported that this was a mitraclip procedure, performed to treat functional mitral regurgitation (mr) of grade 4. The septal puncture was performed and the steerable guide catheter (sgc) was inserted without issue. The clip delivery system (cds) was advanced and positioned. Grasping attempts were made and it was noted that the patient¿s blood pressure decreased. A pericardial effusion was noted. At this time, it was noted that good leaflet insertion was noted and the clip was implanted. Pericardiocentesis was performed. The pericardial fluid continued to drain; therefore, the decision was made to place an atrial septal occluder. After the occluder was placed, the pericardial effusion resolved with time and the blood pressure stabilized. The procedure was completed, with implant of one clip and the mr reduced to grade 1. No additional information was provided.
 
Manufacturer Narrative
The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Manufacturer Narrative
The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
Patient id: (b)(6). This is filed for pericardial effusion, requiring intervention. It was reported that this was a mitraclip procedure, performed to treat functional mitral regurgitation (mr) of grade 4. The septal puncture was performed and the steerable guide catheter (sgc) was inserted without issue. The clip delivery system (cds) was advanced and positioned. Grasping attempts were made and it was noted that the patient¿s blood pressure decreased. A pericardial effusion was noted. At this time, it was noted that good leaflet insertion was noted and the clip was implanted. Pericardiocentesis was performed. The pericardial fluid continued to drain; therefore, the decision was made to place an atrial septal occluder. After the occluder was placed, the pericardial effusion resolved with time and the blood pressure stabilized. The procedure was completed, with implant of one clip and the mr reduced to grade 1. 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 Key13552226
MDR Text Key285822617
Report Number2024168-2022-01663
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,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSGC0705
Device Lot Number10805R249
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2021
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: 02/17/2022 Patient Sequence Number: 1
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