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

Model Number N/A

Device Problems Difficult to Flush (1251); Physical Resistance/Sticking (4012)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

This is filed to report difficulty to flush the device.It was reported that during preparation of the clip delivery system a three-way stopcock was connected to the steerable sleeve (ss) shaft side and air was removed from the ss shaft through the line connected to the pressure bag.However, the device was not filled with the heparinized saline solution and a lot of air remained in the shaft with no continuous dripping from the tip of the device confirmed.The side port of the three-way stopcock was opened and the flow of heparinized saline was confirmed.Troubleshooting was performed by loosening the delivery catheter (dc) fastener and moving the dc handle back and forth.However, the device still did not show continuous dripping from the tip of the device and the dc handle itself had resistance to movement.Per the physicians request, the device was not used and was replaced.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

All available information was investigated, and the reported difficulty flushing the device and delivery catheter (dc) handle resistance were not confirmed during returned device analysis.A review of the lot history record did not indicate a lot-specific quality issue.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, causes for the reported difficulty flushing the device and dc handle resistance could not be determined.There is no indication of 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 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: 15328068
• MDR Text Key: 305163130
• Report Number: 2135147-2022-00959
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/24/2022

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: 09/06/2022
• Device Model Number: N/A
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 10902R264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2021
• 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