MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP NTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-NTR

Device Problem Difficult to Flush (1251)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report during preparation, the clip delivery system (cds) could not be flushed.It was reported that during preparation of the cds, the 3-way stopcock and tubing was connected to the flush-port, but was noted that it was blocked.The saline solution was unable to flow into the cds handle to prep the device; therefore, it was discarded.A new cds was used successfully to complete the procedure.There was no patient involvement 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 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.Based on the information provided a conclusive cause for the reported unable to flush cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10427120
• MDR Text Key: 203848969
• Report Number: 2024168-2020-06921
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• 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: 10/16/2020

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: 11/19/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 91119U168
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 75