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

Model Number SGC0301

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device is returning for analysis, but it has not yet been received, a follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

This is filed to report leak.It was reported that this was a mitra-clip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted that the dilator was not inserted into the valve as stated in the instructions for use.The steerable guide catheter (sgc) was advanced to the mitral valve, however, sgc valve did not seal and blood was seen leaking around the sgc valve.The sgc was removed, and the procedure continued with a new sgc.Reportedly, after the clip delivery system was removed, an 8fr sheath was inserted into the sgc valve to see if it would seal, but it did not seal.Two clips were implanted, reducing mr to <1.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 complaints from the lot.All information was investigated and without the device to analyze, a cause for the reported leak cannot be determined.It should be noted that the mitraclip instructions for use (ifu) states: insert the dilator approximately 10 cm into guide then remove.In this case, it was reported that the dilator was not inserted into the guide during preparation.The reported user error was due to the user not inserting the dilator into the guide during steerable guide catheter (sgc) de-airing steps during preparation; however, it cannot be determined whether the sgc leak during procedure was a result of the user error.There is no indication of a product issue with respect to manufacture, design or labeling.D10, h3: device was not returned.

• 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: 10699136
• MDR Text Key: 211952323
• Report Number: 2024168-2020-08702
• 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: 12/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00622U209
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Age: 62 YR