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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 Problem Perforation (2001)
Event Date 11/12/2021
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 this event. Based on available information, the cause of the reported perforation cannot be determined. Perforation is listed in the mitraclip instructions for use (ifu) as a known possible complication associated with mitraclip procedures. The reported unexpected medical intervention was the result of case-specific circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. The additional device referenced are filed under separate medwatch report number.
 
Event Description
This is filed to report an atrial perforation. It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. It was noted the activated clotting time (act) was greater than 250 throughout the procedure. After the clip delivery system (cds) was inserted into the left atrium (la), a thrombus like object was observed on the clip. The cds was removed and the object remained attached to the clip. Another clip was inserted and successfully deployed on the mitral valve, reducing mr to a grade of <1. However, after the steerable guide catheter (sgc), a left to right shunt was observed. Therefore, an asd closure device was implanted. There was no clinically significant delay in the procedure. 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 Key12952370
MDR Text Key281851668
Report Number2024168-2021-11172
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,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSGC0705
Device Lot Number10512R118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2021
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: 12/07/2021 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP
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