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

Model Number CDS0601-NTR

Device Problems Difficult to Flush (1251); Leak/Splash (1354); Product Quality Problem (1506); Difficult to Open or Close (2921); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The results of the return device analysis did not confirm the reported issues as the device functioned as intended.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.All available information was investigated and a conclusive cause for the reported issues of product quality problem, difficult to flush, device contamination with chemical or other material, leak and difficult to open or close could not be determined in this complaint.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report leak and difficult to flush during preparation of the cds.It was reported that during preparation of the ntr clip delivery system (cds) the clip would not close all the way for it to load into the steerable guide catheter (sgc).It was noted that water sprayed from the handle, the griper line had slack and the intravenous (iv) drip was unable to used properly as the shaft seemed to be occluded.The device was not used.During preparation of the second ntr cds, the clip would not lock properly.Troubleshooting was performed and the clip finally locked but failed to establish final arm angle (efaa).The device was not used.There was no patient involvement with the two devices and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10805592
• MDR Text Key: 215534457
• Report Number: 2024168-2020-09316
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2020

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: 03/17/2021
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 00316U234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1