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

Catalog Number SGC0705

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr), dense fatty tissue, and an enlarged atrium for a mitraclip procedure.After transseptal puncture, the extra stiff guide wire was in the left atrium and the steerable guide catheter (sgc) was loaded over the wire.The sgc could not cross into the vessel.After several attempts it was decided to withdraw the sgc.It was noted that the soft tip of the sgc was not perfectly rounded.A replacement was used to complete the procedure and implant 2 mitraclips.The mr was reduced to grade <1.There was no adverse patient effect or clinically significant delay.

Manufacturer Narrative

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

Event Description

It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr), dense fatty tissue, and an enlarged atrium for a mitraclip procedure.After transseptal puncture, the extra stiff guide wire was in the left atrium and the steerable guide catheter (sgc) was loaded over the wire.The sgc could not cross into the vessel.After several attempts it was decided to withdraw the sgc.It was noted that the soft tip of the sgc was not perfectly rounded.A replacement was used to complete the procedure and implant 2 mitraclips.The mr was reduced to grade <1.There was no adverse patient effect or clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and the reported failure to advance the sgc resulting in the deformed soft tip (deformation due to compressive stress) appears to be related to patient conditions and due to dense fatty tissue.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 18932517
• MDR Text Key: 338020572
• Report Number: 2135147-2024-01229
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0705
• Device Lot Number: 31202R1064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2023
• 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