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

Model Number 96406

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.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).

Event Description

Edwards received notification from our affiliate in germany.As reported, during device preparation, black deposits were found on the inner surface of the 38 ml edwards locking syringe while filling with contrast.A new atrion inflation device was used for the procedure.The patient outcome was good.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually examined for any abnormalities and the following was observed: black particulates within atrion inflation device.Atrion supplier performed evaluation and the following observed: black substance was noted along the inside of the housing.Inner part of the housing exhibits an unknown crystalized substance.Delamination along the inside of the quad ring.Note: the quad ring passed the hardness test (shore a) and the noted delamination could be related to a chemical reaction.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.The complaint of particulate was confirmed based on imagery and returned device provided for evaluation.A review of the dhr, lot history, complaint history, and manufacturing mitigation did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, ''during device preparation black deposits were found on the inner surface of the 38 ml edwards locking syringe while filling with contrast''.Per supplier investigation, ftir material analysis was performed on the black particulate and the test was inconclusive.Atrion was unable to replicate the substance within normal operating parameters and without visibly damaging the quad ring.There are also multiple mitigations such as regular cycling of the device to ensure smooth operation and finished good inspections before the device is packaged for shipment.Therefore, this event is considered an inconclusive isolated event.As the source of contamination remains unknown, a definitive root cause was unable to be determined at this time.Therefore, no further escalation (capa/scar/pra) is required.However, an awareness communication was performed by the supplier as a precautionary measure.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.

Manufacturer Narrative

Supplemental report submitted to include correction: added h6: type of investigation code.

• Brand Name: EDWARDS LOCKING SYRINGE
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 17148475
• MDR Text Key: 317637852
• Report Number: 2015691-2023-13978
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

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 Model Number: 96406
• Device Catalogue Number: N/A
• Device Lot Number: 96406158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 11/10/2023; 11/14/2023
• Supplement Dates FDA Received: 11/13/2023; 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2022
• 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