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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 Leak/Splash (1354)
Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Pericardial Effusion (3271)
Event Date 05/20/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The additional device filed under a separate medwatch report number. Na.
 
Event Description
This is filed to report leak, air embolism, cardiac arrest, pericardial effusion, pericardiocentesis, cpr and hospitalization. It was reported that this was a mitraclip procedure to treat severe degenerative mitral regurgitation (dmr). During use of the steerable guide catheter (sgc) (10204u442), the device would not hold fluid column. After drawing back on the syringe the device would lose the fluid column. Some air bubbles were seen in the anatomy and aspiration was required. The sgc was removed and replaced and again with the new sgc (lot 10217u232), fluid column was lost and aspiration was required although there were no bubbles seen in the anatomy with this device. The second sgc was removed and replaced and there were no issues with the third sgc and mr was reduced to mild. The starting mean pressure gradient (mpg) was 1 mmhg and the ending mpg was 3 mmhg. There were no adverse patient effects during the procedure; however, post procedure the patient coded and was stabilized quickly after cardiopulmonary resuscitation (cpr). There was pericardial effusion which was treated with pericardiocentesis. It is thought that a wire somewhere caused the effusion during the exchange of devices. The patient was hospitalized one additional day. 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 Key11979584
MDR Text Key263496913
Report Number2024168-2021-04906
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,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/04/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10204U442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2021
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: 06/10/2021 Patient Sequence Number: 1
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