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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
Model Number SGC0701
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem Perforation (2001)
Event Date 10/27/2021
Event Type  Injury  
Event Description
This is filed to report septal tear, intervention, difficult to remove. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (dmr) with a grade of 4. Noted very thick posterior leaflet and several calcium nodules on the leaflets. There was difficulty visualizing due to shadowing from the device and the calcium. The clip delivery system (cds) was advanced through the steerable guide catheter (sgc) into the left atrium. While making iterative movements to steer the clip down to the mitral valve, the sgc was mistakenly pulled back into the right atrium. Unsuccessful attempts were made to push the guide back into the left atrium due to interaction with the anatomy. Subsequently, it was attempted to pull the clip back into the sgc but this was not possible and it was assumed that septal tissue was trapped between the clip and the sgc tip. The sgc and clip were very slowly and carefully pulled back into the right atrium together. The clip was then able to be pulled back into the sgc and removed. A small amount of tissue was noted on the end of one clip arm and a septal tear was noted measuring 10 mm on echo. The sgc was removed and re-prepped and advanced through the septal tear. A new cds was prepped and successfully implanted. Moderate to severe mr remained so a second cds was advanced and implanted lateral to the first clip. The residual mr was mild. Post procedure, the septal tear was measured at 16 mm and an atrial septal defect (asd) closure device was successfully implanted. No additional information was provided.
 
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 that would have contributed to the reported event. Additionally, a review of the complaint identified no other complaint reported from this lot. Based on available information, the reported difficult to remove (cds/sgc) and difficult to advance appear to be due to procedural conditions. The reported poor imaging was due to a combination of challenging patient anatomy and procedural circumstances. The reported perforation appears to be a result from reported difficult to remove and difficult to advance issues. The reported patient effect of perforation is listed in the mitraclip system instructions for use (ifu) as a known possible complication associated with mitraclip procedures. Lastly, the reported unexpected medical intervention was a result of case-specific circumstances. There is no indication of product issue with respect to manufacture, design, or labeling. The additional device referenced is being filed under a separate medwatch report number. Na.
 
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 that would have contributed to the reported event. Additionally, a review of the complaint identified no other complaint reported from this lot. Based on available information, the reported difficult to remove (cds/sgc) and difficult to advance appear to be due to procedural conditions. The reported poor imaging was due to a combination of challenging patient anatomy and procedural circumstances. The reported perforation appears to be a result from reported difficult to remove and difficult to advance issues. The reported patient effect of perforation is listed in the mitraclip system instructions for use (ifu) as a known possible complication associated with mitraclip procedures. Lastly, the reported unexpected medical intervention was a result of case-specific circumstances. There is no indication of product issue with respect to manufacture, design, or labeling. The additional device referenced is being filed under a separate medwatch report number. Na.
 
Event Description
This is filed to report septal tear, intervention, difficult to remove. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (dmr) with a grade of 4. Noted very thick posterior leaflet and several calcium nodules on the leaflets. There was difficulty visualizing due to shadowing from the device and the calcium. The clip delivery system (cds) was advanced through the steerable guide catheter (sgc) into the left atrium. While making iterative movements to steer the clip down to the mitral valve, the sgc was mistakenly pulled back into the right atrium. Unsuccessful attempts were made to push the guide back into the left atrium due to interaction with the anatomy. Subsequently, it was attempted to pull the clip back into the sgc but this was not possible and it was assumed that septal tissue was trapped between the clip and the sgc tip. The sgc and clip were very slowly and carefully pulled back into the right atrium together. The clip was then able to be pulled back into the sgc and removed. A small amount of tissue was noted on the end of one clip arm and a septal tear was noted measuring 10 mm on echo. The sgc was removed and re-prepped and advanced through the septal tear. A new cds was prepped and successfully implanted. Moderate to severe mr remained so a second cds was advanced and implanted lateral to the first clip. The residual mr was mild. Post procedure, the septal tear was measured at 16 mm and an atrial septal defect (asd) closure device was successfully implanted. 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 Key12807082
MDR Text Key285173951
Report Number2024168-2021-10324
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCA
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 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/24/2022
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10625R145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2021
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: 11/12/2021 Patient Sequence Number: 1
Treatment
CDS LOT 10616R228.
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