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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
Model Number SGC0701
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Pericardial Effusion (3271)
Event Date 02/01/2021
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. Based on the available information, the reported atrial perforation appears to have been a result of a combination of procedural conditions and challenging patient anatomy. The reported pericardial effusion appears to have been a cascading event of the reported atrial perforation. The reported patient effects of atrial perforation and pericardial effusion as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. The reported additional therapies/non-surgical treatments were results of case-specific circumstances, as pericardiocentesis was performed to treat the pericardial effusion and an atrial septal defect closure device was implanted 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 pericardial effusion and 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. Imaging was difficult due to the anatomy. The clip delivery system (cds) was advanced to the mitral valve. Grasping was difficult due to the restricted posterior leaflet. Transthoracic echocardiogram (tte) noted a pericardial effusion. The patient remained stable and it was decided to proceed with the procedure. Imaging became increasingly more difficult due to the pericardial effusion. Using the same ntw cds, once the leaflets were grasped, and leaflet capture was attempted, the poster leaflet would slip out of the clip. It was decided to not deploy this clip and remove the cds. The physician consulted surgery and a pericardiocentesis was performed. The patient remained stable, they re-positioned the patient, and the imaging improved. Another cds was successfully used in replacement. The clip was implanted with a great grasp and without issues, reducing the mr to grade 2. The transseptal images were re-reviewed and the physician thinks that when the steerable guide catheter (sgc) was advanced, it probably tore a small hole in the posterior transseptal access. As treatment and while using the same sgc in place, the pericardiocentesis catheter was replaced for a non-abbott device and an atrial septal defect (asd) closure device was implanted, resolving the issue. There was no clinically significant delay in the procedure and no adverse patient effects. 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 Key11378815
MDR Text Key233521145
Report Number2024168-2021-01466
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/15/2021
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number01116U216
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 Received02/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2020
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: 02/25/2021 Patient Sequence Number: 1
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