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

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  Injury  

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 and an unstable hemostatic valve.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide (sgc) was inserted into the left atrium (la) and negative pressure was applied when the guide wire and dilator were removed.However, the water level of the sgc started to decrease.It was then noticed that the inside of the column of the sgc was full of heparin saline; therefore, aspiration was performed and the sgc was removed from the anatomy.The sgc was prepared again per the instructions for use (ifu) and it was confirmed that the hemostatic valve worked normally.The sgc was again inserted into the anatomy; however, this time, after removing the guide wire and dilator, the physician stated the hemostatic valve of the sgc was not working as intended as air was unable to be completely removed and the water level of the sgc decreased once more.The sgc was removed and replaced.The cds (clip delivery system) was inserted, but when the clip was attempted to be opened in the anatomy, the clip did not open.Troubleshooting was performed but the clip was still unable to open.Therefore, the clip was removed and replaced.It was noted that all steps were performed per the ifu and when the clip was removed, it successfully opened outside the anatomy.Two additional clips were then successfully implanted, reducing mr to a grade of 1.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leak was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported leaks.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• 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: 10488708
• MDR Text Key: 205515878
• Report Number: 2024168-2020-07350
• Device Sequence Number: 1
• Product Code: DRA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00308U114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 65