MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X100ML; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C08100ML
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A smart control iliac stent 8mm x 100mm would not deploy.Additional information was received and per visual analysis, the stent of the unit was observed deployed approximately 3 mm from the unit.The target lesion is a straightforward superficial femoral artery (sfa).There was no reported patient injury.The product was returned for analysis.One non-sterile smart control, iliac 8x100ml was received for analysis inside a plastic bag.No original packaging was returned.Locking pin was not returned.Per visual analysis, the stent of the unit was observed deployed approximately 3 mm from the unit.The strain relief was observed bent as received.No damages were observed on the tuning dial.No other anomalies were observed.Per functional analysis, a deployment test was performed on the device.The tuning dial was fully rotated.No difficulty was experienced while rotating the tuning dial during the deployment test.Then, the sliding lever was fully pulled, and the stent was successfully released.No anomalies were observed on the stent.A product history record (phr) review of lot 17894151 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses - deployment difficulty - partial deployment " was confirmed since the stent was received partially deployed.Nevertheless, functional test was performed, and the stent was successfully deployed from the unit.Also, the strain relief was observed bent, as received.Handling and or procedural factors such as vessel characteristics (although unknown) and user technique may have led to the reported event.According to the instructions for use ¿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.Neither the product analysis nor the phr review suggests that the event experienced by the customer is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As reported, the 8mm x 100mm iliac smart control stent would not deploy.Additional information was received and per visual analysis, the stent of the unit was observed deployed approximately 3 mm from the unit.There was no reported patient injury.The target lesion is a straightforward superficial femoral artery (sfa).The device will be returned for analysis.

• Brand Name: SMART CONTROL, ILIAC 8X100ML
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 10445906
• Report Number: 9616099-2020-03865
• Device Sequence Number: 4092339
• Product Code: FGE
• UDI-Device Identifier: 20705032024225
• UDI-Public: 20705032024225
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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
• Operator of Device: Health Professional
• Device Model Number: C08100ML
• Device Catalogue Number: C08100ML
• Device Lot Number: 17894151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1