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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER CATHETER, STEERABLE Back to Search Results
Model Number SGC0301
Device Problems Fluid Leak (1250); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2020
Event Type  malfunction  
Event Description
Hemostatic valve failure on steerable guide, i. E. , leaking, and a new device was opened and used. Procedural note: "the right groin region was anesthetized with 20ml of xylocaine. The common femoral vein was accessed and two proglide devices were deployed. The patient was fully anticoagulated. We took an sl0 transseptal sheath and a bk needle and a transseptal puncture was performed about 4 cm from the mitral annulus. We then positioned the amplatz wire in the left upper pulmonary vein. We used dilators and then advanced a 24-french guide sheath. Upon removing the wire and the dilator, the ____ was lost within the guide sheath. We tried to reposition the guide sheath within the left atrium in case we were against the wall, but it kept losing the ____. This was suggested that there is something faulty with the device, although it appeared to be okay pre-introduction into the body. We therefore advanced a safari small curve into the left atrium, removed the guide sheath, and introduced a new guide sheath. We then proceeded to position a mitraclip ntr grasping the anterior and posterior mitral leaflets just lateral to a2 and p2. Our mean gradient average was 3 mmhg. The worst degree of mitral regurgitation was 1+. This was a medial jet that we were not going to pursue due to the baseline mean gradient of 3 mmhg. There was good tissue bridge. The device was released. No changes were noted after the device was released. The guide sheath was removed and two proglide devices were deployed with good hemostasis. The patient was sent to recovery room in stable condition. ".
 
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Brand NameSTEERABLE GUIDE CATHETER
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
ABBOTT VASCULAR
3200 lakeside dr
santa clara CA 95054
MDR Report Key10118386
MDR Text Key194001517
Report Number10118386
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00214U117
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2020
Event Location Hospital
Date Report to Manufacturer06/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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