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

Model Number 96406

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

As reported from our affiliates in poland, during a transcatheter aortic valve implantation case with a 29mm valve, the inflation syringe started to leak during valve deployment.The leak started about halfway through the valve expansion.The syringe was replaced, and the valve implantation was completed successfully.The rapid pacing phase was about 10 seconds longer than normal (approximately 20-25 seconds in total).The patient felt well, and the procedure was successful.There were no abnormalities on the packaging, and the syringe was not dropped.The syringe only leaked under pressure.The commander delivery system was de-aired with negative pressure in the syringe and there were no signs of malfunction of syringe or leaking.The leaking only started during inflation of the valve.

Manufacturer Narrative

The edwards locking syringe commercialized in europe by edwards lifesciences is similar to the marketed device in the united states by atrion medical products, inc.Under 510k (k060643).Investigation is ongoing.

Manufacturer Narrative

Added h6 type of investigation and investigation findings corrected h6 component code and investigation conclusions the device was returned in the unlocked position with slight moisture inside the barrel.Visual inspection of the returned device was performed, and the following was observed: crack observed on distal end of barrel beginning from 5cc mark, protruding to hose bond area, 1 to 1.25" in length.Black marked abrasions at proximal end of crack.Device under polariscope shows limited residual stress in crack location.Sink mark observed on hose-socket cavity.Device exhibits a crack from the 5cc mark up to the hose socket of the housing.Functional testing was performed and the following was observed: the inflation device was pulled negative, and no bubbles or leakage was observed.Under inflation/depressing the plunger, leakage was observed from the crack on the barrel.The inflation device was aspirated and the leakage from the barrel was confirmed.Review of procedural videos/imagery/photographs were performed, and the following was observed: screenshot of post-procedural video shows leakage from the barrel during inflation.Screenshot of procedural cine shows partial expansion of valve when leakage was noticed.The complaint for leakage was confirmed based on the condition of device return.A potential supplier manufacturing nonconformance was identified during the evaluation.A review of the ifu and training manuals revealed no deficiencies.A complaint history review on confirmed device complaints (returned and no product returned) from april 2021 to march 2022 for the edwards inflation device (all models and sizes) revealed additional similar complaints for leakage.The complaints were confirmed, but no manufacturing non-conformities that would have contributed to the reported events were identified.Available information suggested that procedural factors may have contributed to the complaint events.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.As reported, "the inflation syringe started to leak." device inspection identified a crack on the distal end of the barrel near the hose bond area.Functional testing confirmed the leak during inflation only (pressurized) as the device was able to hold/maintain vacuum.The device was forwarded to the supplier and further investigation revealed sink at the hose socket bond cavity.The potential root cause is believed to be a housing with higher molded in stress in combination with solvent that is more aggressive than normal, possibly due to moisture content, leading to crack formation and the subsequent leak in the barrel of the housing.In response to this complaint and the complexity of the corrective actions identified for implementation, a capa has been opened to document the root cause analysis and track implementation of the corrective and preventative actions.As a potential supplier manufacturing non-conformance was identified, a product risk assessment determination has been initiated.Replication studies are in-process at the suppler and a supplier corrective action request was initiated to capture the investigation and related actions.

• Brand Name: EDWARDS LOCKING SYRINGE
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13943284
• MDR Text Key: 297347335
• Report Number: 2015691-2022-04704
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/07/2022

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 Model Number: 96406
• Device Catalogue Number: N/A
• Device Lot Number: 96406140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2021
• 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