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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 Problem Low Blood Pressure/ Hypotension (1914)
Event Date 02/10/2022
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 this event. Based on the information reviewed, a cause for the reported hypotension could not be determined. Hypotension is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures. The reported unexpected medical intervention was a result of case specific circumstance. There is no indication of a product issue with respect to manufacture, design or labeling.
 
Event Description
This is being filed to report the hypotension requiring intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. After insertion of the steerable guide catheter (sgc), the patients blood pressure suddenly dropped significantly and could not be measured anymore. After application of adrenaline, the patients blood pressure normalized. The procedure was completed with one clip implanted, reducing mr to 1-2. 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 Key13618269
MDR Text Key286231427
Report Number2024168-2022-02053
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
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number10719R319
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2021
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: 02/28/2022 Patient Sequence Number: 1
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