MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; INTRODUCER, CATHETER

Model Number 9610ES16

Device Problems Nonstandard Device (1420); Particulates (1451)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Edwards received notification from our affiliate in (b)(6).As reported, this was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve.During preparation of the esheath, a small defect was noted and some particles of the light-blue material came out of the package.It seemed that the esheath was not finished up to the top during manufacturing.Therefore, the esheath was not used.It was decided to open a second kit to continue with the procedure.The procedure was completed successfully.The patient final outcome was good.Per pre-decontamination evaluation, 2 areas of unknown clear material stain were noted on the esheath.There was no blue material or any other material observed in the returned packing.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually inspected, and the following was observed: the sheath was unexpanded and the tip was unopened.Packaging was received unsealed.There was no blue material or any other material in the returned packaging.Clear material observed on the hdpe surface located 2cm from the strain relief with a size of approximately 1.5cm x 0.5cm.Clear material observed on the hdpe surface located 0.5cm from the distal tip with a size of approximately 0.5x0.2cm.Sheath shaft noted to be damaged at same location as the clear material located near the strain relief.The hdpe was scratched and slightly peeled back but no missing pieces were apparent.Material analysis was performed on the isolated clear material collected during product evaluation with fourier transform infrared spectroscopy (ftir) and a summary of the results were captured below.Ftir results for the clear material found on the sheath shaft show similar absorption characteristics as polyvinylpyrrolidone (pvp), one of the main components of the hydrophilic coating.A dye test was performed to test for hydrophilic coating coverage in the two regions along the sheath shaft exhibiting the clear material anomaly.The sheath shaft was wetted with a red dye.The dye adheres to the hydrophilic coating to show where the coating is present on the shaft.The results of this test show that coating was not fully present along the tested areas; however, this is likely due to the device having been handled during unpacking and preparation.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this event.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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 system components anomaly was confirmed through evaluation of the returned device.The complaint sheath shaft particulate was empirically confirmed through evaluation of the returned device.However, no manufacturing non-conformances that would have contributed to the reported event were identified.Review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint event.A review of ifu/training materials revealed no deficiencies.Per the complaint description, 'it seemed as if it had not really finished up to the top during manufacturing'.Additionally, per evaluation of the returned device, two regions on the sheath shaft with clear material.Ftir testing revealed that the clear material closely matches one of the main components of the hydrophilic coating (pvp).The dye test showed presence of hydrophilic coating, indicated by the adherence of the dye to the coating along the shaft, near the distal tip, and on the observed clear material.The results of this test also showed that the coating was not fully present along these areas, which is likely due to the device having been handled during unpacking and preparation.It is likely that after preparing the sheath and activating the hydrophilic coating, the coating dried to create the observed bunching of clear material.Further device handling likely further altered the presence of the hydrophilic coating along the shaft.As such, available information suggests that procedural factors (device handling) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.No ifu/labeling/training manual inadequacies or manufacturing nonconformance were identified.Therefore, no corrective or preventative actions is required at this time.A product risk assessment (pra) was previously initiated for further investigation and risk assessment relating to hydrophilic coating flaking.Per the complaint description, 'during preparation of the 16fr esheath (29mm sapien 3 case), a small defect on the esheath was noticed, and some particles of the light-blue material came out of the package'.Evaluation of the returned device revealed that the hdpe located at the clear material near the strain relief was damaged (figure 5).It is possible that the reported 'light blue' material may have originated from this damaged area on the shaft.It is possible that the sheath was mishandled during unpacking or preparation, leading to the damage of the hdpe and the potential shedding of material.As such, available information suggests that procedural factors (sheath damaged during unpacking/preparation) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.No ifu/labeling/training manual inadequacies or manufacturing nonconformance were identified.Therefore, no corrective or preventative actions is required at this time.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.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• 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: 13426247
• MDR Text Key: 284979179
• Report Number: 2015691-2022-03755
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103193244
• UDI-Public: (01)00690103193244(17)230809(10)63935298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 63935298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2021
• 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