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

Catalog Number SGC0302

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received, but investigation has not been completed.A follow up report will be submitted with all additional relevant information.Na.

Event Description

This is filed to report a leak.It was reported that during preparation of the steerable guide catheter (sgc), the guide tip was submerged in the basin of heparinized saline, and the physician removed their finger to check the water level of the hemostasis valve; however, the water level immediately dropped, and air entered.It was confirmed the three-way stopcock was closed; therefore, the guide tip was again submerged in the basin of heparinized saline.However, the same issue occurred.The extension tube was reattached, and the guide tip was submerged.This time, the water level remained steady, but after roughly 20 seconds, the water level began to drop.The physician decided to not use the device and replaced it.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leaks could not be 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.

• 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: 10393381
• MDR Text Key: 202517355
• Report Number: 2024168-2020-06688
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00213U347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1