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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 Hematoma (1884)
Event Date 12/12/2021
Event Type  Injury  
Event Description
This is filed to report the hematoma. (b)(4). It was reported that this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr), with an mr grade of 4. The left and right atrium were dilated. The posterior mitral valve leaflet was tethered and there was a flail on the anterior mitral leaflet. Two clips were implanted reducing mr to 2. A third clip was advanced to further reduce the lateral mr. Echocardiogram was massively reduced. Grasping the leaflets was difficult due to the anatomy, imaging and due to the prior implanted clips. The clip was able to be placed and mr was reduced to 1. However, after clip deployment mr was at grade 3. The clip may not have had sufficient posterior leaflet captured. Tissue damage or leaflet injury is suspected. The clip remained secure on the leaflets. No additional clips were implanted. Mr was reduced to 3. On (b)(6) 2021, the patient had an access site complication, a hematoma was observed in the right groin. It is unknown if the sgc caused or contributed to the hematoma. The size of the hematoma is unknown, it was described as a large hematoma without connection to the vessel. Sandbag compression therapy was used. The hematoma resolved on (b)(6) 2021. Additional hospitalization was not required as the patient was still hospitalized for the procedure. No additional information was provided.
 
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. The reported hematoma, as listed in mitraclip g4 clip delivery system and steerable guide catheter information for use is a known possible complication associated with mitraclip procedures. Based on available information, a cause for the reported hematoma could not be determined. The reported medical intervention is the result of case-specific circumstances there is no indication of a product quality issue with respect to manufacture, design, or labeling. The additional mitraclip device is filed under separate medwatch report number.
 
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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 Key13967545
MDR Text Key288305523
Report Number2024168-2022-03414
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,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number10616R243
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2021
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: 03/31/2022 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP(X2)
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