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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 Problems Difficult or Delayed Positioning (1157); Difficult to Advance (2920)
Patient Problems Hemorrhage/Bleeding (1888); Respiratory Failure (2484); Unspecified Tissue Injury (4559)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
The device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report hemorrhage, intervention, delay, tissue injury. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mmr) with a grade of 4. The steerable guide catheter (sgc) was difficult to advance through the non-abbott sheath after puncturing the atrial septum and it was expanded with a 5x20 mm balloon dilatation catheter. The sgc was then able to pass through although there was resistance. Next, the clip delivery system (cds) was advanced to the mitral valve and noted small prolapse on the a2 medial site. The clip was placed in the center of a2p2 and mild mr could be seen on the medial side of a2p2 but mr decreased significantly to grade of 1. No device issues were noted with the cds and there were no adverse patient effects due to the cds. When the patient was waking from anesthesia, there was bleeding noted from the bronchi. It is suspected that the likely cause was damage to the pulmonary veins caused by the guide wire during insertion of the sgc. The heparin was neutralized with protamine and the patient returned to the room with intubation. Positive pressure ventilation is being used to promote hemostasis. The patient was extubated the next day and there was no prolonged hospitalization. There was a 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 Key12033618
MDR Text Key257209641
Report Number2024168-2021-05204
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/11/2022
Device Catalogue NumberSGC0705
Device Lot Number10112U133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2021
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: 06/21/2021 Patient Sequence Number: 1
Treatment
CDS LOT 10128U160; SWARTZ SHEATH
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