MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-NTW

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

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report sterility unknown.It was reported that the customer received the outer box of the clip delivery system (cds) damaged with tears.It is unknown at this time if the sterility is intact.The cds was not opened or used in a procedure.There was no patient and involvement and no clinically significant delay in the procedure.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

All available information was investigated, and the reported tear, rip, or hole in the device packaging was not confirmed via returned device analysis.However, damage to the short edge of the shelf carton was confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the available information, a cause for the reported tear, rip, or hole/damage to the shelf carton could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12128483
• MDR Text Key: 261253552
• Report Number: 2024168-2021-05771
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

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: 02/22/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10222R329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1