MAUDE Adverse Event Report: CORDIS US CORP. SMART FLEX; CATHETER, PERCUTANEOUS

Catalog Number SF06060MB

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 323138 presented no issues during the manufacturing process that could be related to the event reported.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the catheter shaft of a smart flex 6x60 self-expanding stent delivery system snapped while being delivered to the treatment site causing ¿geographic miss¿ with the stent as it had to be deployed prematurely to avoid risk to patient.The deployment shaft distal to the tuohy-borst was kinked/bent resulting in inability to advance the stent and necessity of deployment where it was currently.The totality of the lesion was not covered by the stent, as it should have been.A second stent was then placed to cover the rest of the lesion.There was no reported patient injury.There was minimal resistance/friction during insertion of the device.The delivery of the sds to the lesion was contralateral.Moderate difficulty was encountered while advancing/tracking the sds towards the lesion.The intended procedure was reported to be stenting of the superficial femoral artery (sfa).The target lesion was reported as a recalcitrant plaque in the sfa.The lesion was not calcified and not tortuous.The device was stored, handled, and prepped as per the instructions for use (ifu) with no difficulty in prepping the device.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer sheath when removed from the tray.The diameter of the unconstrained stent was sized larger than the target area.There was no unusual force used at any time during the procedure.The area was not predilated; this was primary stenting.

Manufacturer Narrative

The catheter shaft of a smart flex 6x60 self-expanding stent delivery system snapped while being delivered to the treatment site causing ¿geographic miss¿ with the stent as it had to be deployed prematurely to avoid risk to patient.The deployment shaft distal to the tuohy-borst was kinked/bent resulting in inability to advance the stent and necessity of deployment where it was currently.The totality of the lesion was not covered by the stent, as it should have been.A second stent was then placed to cover the rest of the lesion.There was minimal resistance/friction during insertion of the device.The delivery of the sds to the lesion was contralateral.Moderate difficulty was encountered while advancing/tracking the sds towards the lesion.The intended procedure was reported to be stenting of the superficial femoral artery (sfa).The target lesion was reported as a recalcitrant plaque in the sfa.The lesion was not calcified and not tortuous.The device was stored, handled, and prepped as per the instructions for use (ifu) with no difficulty in prepping the device.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer sheath when removed from the tray.The diameter of the unconstrained stent was sized larger than the target area.There was no unusual force used at any time during the procedure.The area was not predilated; this was primary stenting.There was no reported patient injury.The device was returned for analysis.A non-sterile unit of product ¿smart flex 6x60 bil, 120cm¿ was received coiled inside of a clear plastic bag.The device was unpacked and was laid flat on a tray to proceed with the product evaluation.The unit was returned fully deployed.The stent was not returned for analysis.The hemostasis valve is open.Several kinks were noticed located approximately at 19, 23, and 43 cm from the distal tip.An outer sheath separation is observed located approximately at 117 cm from the distal tip.No other damages or anomalies were observed on the returned device.Functional test was not performed due to the separation condition on the outer sheath and due to the unit was returned fully deployed.The separated area was analyzed using a vision system to magnify the damage area.Results showed that the edges on the separated area presented evidence of elongations.The elongations found on the plastic material and the plastic deformation are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.A product history record (phr) review of lot 323138 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.The reported ¿outer sheath - cracked¿ was not confirmed, no cracked condition was observed on the outer sheath.However, an ¿outer sheath~separated¿ condition was confirmed.The reported ¿stent delivery system (sds)~deployment difficulty-inaccurate placement¿ was not confirmed due to the stent was received fully deployed and due to the nature of the complaint.Also, a kinked condition was found.The exact cause of the observed separated and kinked condition could not be determined during the product analysis.It is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.Procedural factors and handling process such as the user¿s interaction with the device during use may have contributed to reported events.According to the instructions for use (ifu) ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to the stent or lumen.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Prior to stent deployment, remove all slack from the catheter delivery system.¿ the product evaluation does not suggest that the observed damages are related to the manufacturing process; therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SMART FLEX
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 15 christopher way; eatontown, new jersey 07724 ; 7863138372
• MDR Report Key: 17192898
• MDR Text Key: 317769477
• Report Number: 3005089785-2023-00125
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032066041
• UDI-Public: (01)20705032066041(17)250125(10)323138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

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 Catalogue Number: SF06060MB
• Device Lot Number: 323138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• 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