MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP NTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0601-NTR

Device Problems Difficult to Flush (1251); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the inability to flush the port during preparation.It was reported that during preparation of the mitraclip delivery system, it was difficult to flush the port.It was suspected that there was an obstruction within the port.Additionally, the red cap was not in the correct place, it was free floating inside the package.The device was not used in the anatomy and was replaced.A new device was used to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the device was returned.The reported difficult to flush was confirmed during returned device analysis as blockage was noted within the handle luer.A review of the lot history record identified no exception issued to the reported lot that would have contributed to this issue.Additionally, a review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the reported device misassembled during manufacturing or shipping could not be determined as the cap was not returned and the reported issue could possibly be due to device shipping/handling process; however, this cannot be confirmed.Based on the information reviewed and the return device analysis, the reported difficult to flush was confirmed due to observed blockage within the delivery catheter (dc) flush port luer.It was determined that the cause is potentially related to manufacturing.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: MITRACLIP NTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8505716
• MDR Text Key: 141750176
• Report Number: 2024168-2019-02833
• Device Sequence Number: 1
• Product Code: NKM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

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: 01/24/2020
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90123U270
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1