MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Model Number SGC0301

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report difficulty removing.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted that visualization was very poor due to difficulties with echocardiography.The steerable guide catheter (sgc) was inserted and advanced into the left atrium (la).The clip delivery system (cds) was advanced into the la; however, at this time, the sgc lost transseptal access.The clip remained in the la during this time.It was noted that no unintended movement occurred with the sgc and the loss of transseptal was due to poor visualization.Transseptal access was attempted to be achieved again, but the soft tip of the sgc became caught on the clip.Both devices were successfully removed without any issues.It was noted that no damage occurred to the tip of the sgc.The sgc was reinserted and transseptal access was attempted to be achieved.However, the sgc was unable to cross the septum; therefore, the sgc was removed and the procedure was discontinued.There were no adverse patient effects and no clinically significant delay in the procedure.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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated, and the reported unintended movement was due to poor visualization.The poor image resolution, difficult to remove was due to user technique/procedural circumstances.Lastly, the cause for failure to advance could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10075912
• MDR Text Key: 191601647
• Report Number: 2024168-2020-04432
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 90923U106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM