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 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received.Evaluation has not yet begun.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the steerable guide catheter leak.It was reported that this was a mitra clip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc), was inserted and crossed the septum.However, after removing the dilator and guide wire from the sgc, the sgc hemostasis valve did not close, and air entered the sgc.Additional aspiration was not needed.The sgc was removed and a new sgc was used.No air entered the patient.Three clips were implanted, reducing mr to 1.There was no adverse patient effect, or a clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported leak was not confirmed via returned device analysis.The discrepancy between what was reported and what was observed (no leaks) may have been due to the user technique during the procedure versus the returned product analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.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.It is possible that the user technique of removing the dilator and guide wire contributed to the reported leaks; however, this cannot be confirmed.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: 10901155
• MDR Text Key: 218249963
• Report Number: 2024168-2020-09907
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00501U122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1