MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS INFLATION DEVICE; SYRINGE, BALLOON INFLATION

Model Number 96402

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our edwards lifesciences japanese affiliate, during device preparation for tavr procedure of 23 mm sapien 3 ultra resilia (s3ur), upon de-airing of an atrion inflation device, dirt on the scale inside of the indeflator was observed that looked like something black had been scraped off, and something that looked like black rubber was stuck to it.A new indeflator was opened from single item use and the procedure was completed without any problems.

• Brand Name: EDWARDS INFLATION DEVICE
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18956422
• MDR Text Key: 338610504
• Report Number: 2015691-2024-02198
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

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 Model Number: 96402
• Device Lot Number: 96402R007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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