MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr), aorta hugger, low-transseptal puncture, and a rotated heart which affected the imaging capability of the mitraclip procedure.Transseptal access was achieved with abnormal anatomical findings.The transseptal puncture was low and anterior, and height was needed to be gained to steer the clip down to the valve.To correct the aorta hugger trajectory, + knob was applied (approximately 3/4 of a full turn), resulting in the clip delivery system (cds) being curved more than 90 degrees.Height was achieved with posterior rotation of the steerable guide catheter (sgc) and a knob was applied.It was noted that an abnormal amount of a knob was needed to achieve proper height.Upon steering the clip to the target site, grasping was attempted and successful.After a thorough leaflet, mr, and gradient assessments, it was decided continue to deployment and evaluate the final mr grade.Prior to establish final arm angle (efaa), it was discovered that the clip was not completely closed to the final arm angle (faa).This was noted via fluoroscopy, and the clip arm angle was estimated at approximately 40 degrees.Several attempts were made to close the clip to a faa of 20 degrees, but was unsuccessful.It was decided to release the grasp and remove the clip.After the clip was moved back into the atrium, a knob was removed from the sgc and the clip was able to close slightly less than the previous attempts.The clip was not able to be completely retracted into the sgc.After several attempts to close down enough to retract the clip into the sgc, it was determined by the implanting md to bring the sgc and cds into right atrium thru septum with clip being exposed.Success was achieved and left groin access was accessed to bring in a snare device to attempt to close the clip down.That was a successful maneuver, and the clip was completely taken into the sgc.The clip was removed and access was maintained.The sgc was rewired to maintain access, and subsequently removed and replaced due to potential damage to the soft tip during attempts to remove the clip.Once removed, the soft tip was observed to be wrinkled (not smooth).Upon placing the new sgc, 2 xtw clips were implanted, the final mr grade was <1, and the final gradient was 2mmhg.There were no averse patient sequelae.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19210346
• MDR Text Key: 341358762
• Report Number: 2135147-2024-01904
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: (01)08717648231025(17)250716(10)40117R1037
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0701
• Device Lot Number: 40117R1037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2024
• 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: MITRACLIP
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 83 KG