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

Model Number SGC0301

Device Problems Leak/Splash (1354); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report a leak.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.A steerable guide catheter (sgc) was advancing but could not cross the septum.The septum was too small.Therefore, the sgc was removed and the septum was ballooned.The sgc was re-prepped; however, loss of fluid column was observed.The sgc was not re-introduced in the patient and the procedure continued with a new sgc.One clip was implanted, reducing mr to 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis could not replicate the reported failure to advance issue.The reported leak was confirmed based on the observed broken/damaged flush port luer.A review of the lot history record identified no exceptions issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The reported failure to advance appears to be due to user technique/procedural circumstance.Based on the information reviewed and the return device analysis, the reported leak was confirmed based on the observed broken/damaged flush port luer.The investigation determined the noted broken/damaged flush port luer appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 10869054
• MDR Text Key: 217147573
• Report Number: 2024168-2020-09740
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91114U153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 119