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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 Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Event Date 04/05/2022
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report suspected embolism, thrombus, low blood pressure, congestive heart failure and septal shunting requiring medication. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4. Two clips were successfully implanted reducing mr to <1. All devices were reported to have functioned as intended. While closing the femoral puncture site, the patient decompensated and blood pressure dropped. The right side of the heart appeared to have increased pressure load as the septum was displaced to the left and, right to left septal shunting was observed. The patient was treated with a bolus of arterenol and stabilized. Right heart pressure improved and septal shunting returned to left to right again. In the physician's opinion, a small pulmonary embolism was suspected to have caused the noted events and the sgc may have loosened a thrombus already in the venous system. Following the procedure, the patient was noted to be alert, oriented, and stable. There was no clinically significant delay in the procedure and no adverse patient sequelae. 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 Key14239145
MDR Text Key290306477
Report Number2024168-2022-04623
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/05/2022
Device Catalogue NumberSGC0702
Device Lot Number10406R203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2021
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: 04/28/2022 Patient Sequence Number: 1
Treatment
TWO IMPLANTED MITRACLIPS
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