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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 Problems Hypoxia (1918); Perforation (2001)
Event Date 10/14/2021
Event Type  Injury  
Event Description
This is filed to report the atrial perforation. It was reported that this was a mitraclip procedure performed to treat mixed mitral regurgitation with an mr grade of 3-4. The septum was floppy. Two clips were implanted without issue. However, after retracting the steerable guide catheter (sgc) into the right atrium, there was a right to left shunt with o2 oxygenation of 82%. A septal occluder was implanted and some shunt remained. During advancement of the wire to implant a second occluder, the first occluder jumped out of the septum and into the left atrium. A snare device was used to retrieve the occluder. The second occluder was placed, resolving the shunt and deficiency in oxygen. The patient left the cath lab in stable condition. No additional information was provided.
 
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. The reported patient effect of cardiac perforation as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures. Based on the information reviewed, the reported perforation resulting in hypoxia was likely related to procedural conditions. The reported 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.
 
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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
MDR Report Key12733992
MDR Text Key280522302
Report Number2024168-2021-09836
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Catalogue NumberSGC0702
Device Lot Number10429R244
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/01/2021 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP(X2)
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