MAUDE Adverse Event Report: CORDIS CORPORATION SES SMART CONTROL 10X80 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number C10080SV

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant devices: (sheathlesspv, asahi intecc), (vassallo, filmec) complaint conclusion: a smart control stent (10x80mm 80cm) was inserted and attempted to cross the lesion; however, it¿s ¿outer¿ was frayed so it could not cross the lesion.It was removed from the patient body and was replaced with a new stent of the same size.The procedure was completed.There was no reported patient injury.The device has been discarded in the hospital due to suspicious infectious disease.The lesion was the superficial femoral artery.Initially, a contralateral approach was made with a non-cordis guiding catheter to make a cross-over approach.An intravascular ultrasound (ivus) checked the lesion after a non-cordis guidewire crossed the lesion and an unknown balloon catheter (5mm) was inserted and inflated.The product was not returned for analysis.A product history record (phr) review of lot 17745040 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip frayed/split/torn - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, may have contributed to the reported event.According to the safety information in the instructions for use ¿generally, contraindications to pta are also contraindications for stent placement.Contraindications include, but may not be limited to: patients with highly calcified lesions resistant to pta.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, a smart control stent (10x80 80) was inserted and attempted to cross the lesion; however, its ¿outer¿ was frayed so it could not cross the lesion.It was removed from the patient body and was replaced with a new stent of the same size.The procedure was completed.There was no reported patient injury.The device has been discarded in the hospital due to suspicious infectious disease.The lesion was the superficial femoral artery.Initially, a contralateral approach was made with a non-cordis guiding catheter to make a cross-over approach.An intravascular ultrasound (ivus) checked the lesion after a non-cordis guidewire crossed the lesion and an unknown balloon catheter (5mm) was inserted and inflated.

• Brand Name: SES SMART CONTROL 10X80 80
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 43017
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8892689
• MDR Text Key: 197330084
• Report Number: 9616099-2019-03146
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2019

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 Expiration Date: 12/31/2019
• Device Model Number: C10080SV
• Device Catalogue Number: C10080SV
• Device Lot Number: 17745040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2018
• 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