MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0705-NTW

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported a mitraclip ntw device was received at the hospital damaged.The inner and outer packaging were both damaged.It was noted the sterility of the inner packaging was breached.The product was not used and returned.No additional information was provided.

Manufacturer Narrative

This is a duplicate of e-189990.Since an initial report has already been filed, a follow up mdr is required.The analysis will be captured in e-189990.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18193893
• MDR Text Key: 328821962
• Report Number: 2135147-2023-05167
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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: 04/17/2024
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 30419R1035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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