MAUDE Adverse Event Report: CORDIS CORPORATION SES SMART CONTROL 8X100 120; CATHETER, BILIARY, DIAGNOSTIC

Model Number N/A

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

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

During the advancement of a smart control 8mm x 100mm 120 self-expanding stent (ses) delivery system, it was noted that the head of the device was damaged.The tip of the sheath catheter was "bifurcated", split during advancement into the lesion.The procedure was completed using another unknown stent.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The unknown intended lesion was not located at the carotid bifurcation.A 6f non cordis sheath introducer was used using an ipsilateral approach.There was no guide catheter used.The unknown target lesion had 50% stenosis with mild calcification and no tortuosity.The stent delivery system did not pass through any acute bends.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17950861 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.Without the return of the device for analysis the reported catheter tip~ frayed/split/torn - in patient was not confirmed.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device and vessel characteristics (50% stenosis with mild calcification) may have contributed to the reported event.According to the instructions for use (ifu) ¿ensure locking pin is still in place.Note: if the locking pin is not in place, system performance may be compromised, and another system should be used.Advance the stent delivery system over the guidewire through the sheath introducer to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Caution: always use an appropriate size introducer sheath for the implant procedure to protect vessel and access site.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

During the advancement of an 8mm x 100mm 120 smart control self-expanding stent (ses) delivery system, it was noted that the head of the device was damaged.The tip of the sheath catheter was "bifurcated", split during advancement into the lesion.The procedure was completed using another unknown stent.There was no reported patient injury.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The unknown intended lesion was not located at the carotid bifurcation.A 6f non cordis sheath introducer was used using an ipsilateral approach.There was no guide catheter used.The unknown target lesion had 50% stenosis with mild calcification and no tortuosity.The stent delivery system did not pass through any acute bends.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will not be returned for evaluation as it was already discarded due to infectious disease.

• Brand Name: SES SMART CONTROL 8X100 120
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 11699196
• MDR Text Key: 247774965
• Report Number: 9616099-2021-04446
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: C08100MV
• Device Lot Number: 17950861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2020
• 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
• Patient Age: 68 YR
• Patient Weight: 70