MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

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.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, 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 Key: 12807082
• MDR Text Key: 285173951
• Report Number: 2024168-2021-10324
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10625R145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CDS LOT 10616R228.
• Patient Outcome(s): Required Intervention