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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 Problems Difficult or Delayed Positioning (1157); Leak/Splash (1354)
Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)
Event Date 02/04/2022
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no other complaints from the lot. All information was investigated, and the difficult positioning associated with difficulty crossing the septum with the steerable guide catheter (sgc) appears to be related to the suboptimal transseptal puncture and therefore, related to patient conditions. However, a cause for the reported sgc leak cannot be determined. The reported air embolism resulting in hypotension appears to be related to the procedural conditions associated with the sgc leak. Air embolism and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures. The unexpected medical intervention was a result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report leak, air embolism and medical intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. It was noted suboptimal transseptal puncture. The steerable guide catheter (sgc) crossed the septum; however, crossing the septum was difficult due to the suboptimal transseptal puncture and air was observed in the left atrium. Additionally, the patient's blood pressure dropped. Therefore, the 3-way stopcock was opened and closed. No new air was observed. Medication was administered to treat the blood pressure drop and stabilize the patient. The procedure continued, and a clip delivery system (cds) was advanced through the sgc. However, due to an aorta hugger, the cds was difficult to orient above the leaflets. Troubleshooting was unsuccessful, therefore a decision was made to make another transseptal puncture. The septum was punctured 2 cm above the fossa ovalis and the procedure continued. The cds was advanced to the mitral valve, and the clip was deployed. One clip was implanted, reducing mr to 1. 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 Key13578132
MDR Text Key287112207
Report Number2024168-2022-01845
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 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSGC0702
Device Lot Number10909R256
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2021
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: 02/22/2022 Patient Sequence Number: 1
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