MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL; THROMBECTOMY SYSTEMS

Model Number N/A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During insertion of the sheath within an optease retrieval filter kit, the distal end of the sheath became frayed.Therefore, it was replaced with a new optease and it could be inserted.There was no reported patient injury.The device will not be returned for analysis because of an emergent procedure.An approach was made from the femoral artery.The product appeared normal when taken from its packaging.There was no difficulty flushing or assembling the devices.The access site was not a chronic total occlusion (cto) and did not have any stenosis.There was no excessive force used to insert the sheath.A dilator was used prior to inserting the sheath.The product appeared normal when taken from its packaging.There was no difficulty flushing or assembling the devices.The access site was not a chronic total occlusion (cto) and did not have any stenosis.There was no excessive force used to insert the sheath.A dilator was used prior to inserting the sheath.

Manufacturer Narrative

During insertion of the sheath within an optease retrieval filter kit, the distal end of the sheath became frayed.Therefore, it was replaced with a new optease and it could be inserted.There was no reported patient injury.The device will not be returned for analysis because of an emergent procedure.An approach was made from the femoral artery.The product appeared normal when taken from its packaging.There was no difficulty flushing or assembling the devices.The access site was not a chronic total occlusion (cto) and did not have any stenosis.There was no excessive force used to insert the sheath.A dilator was used prior to inserting the sheath.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Without the return of the product for analysis, the event reported by the customer as ¿brite tip (csi/filters)- frayed/split/torn¿ could not be confirmed.Procedural factors, (such as interaction of the cannula sheath with a concomitant vessel dilator or guide wire) may contribute to the failure as reported.According to the instructions for use (ifu), ¿a vessel dilator facilitates the percutaneous entry of the csi by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.If increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.¿ based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: OPTEASE RETR FILTER 55 FEMORAL
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8037464
• MDR Text Key: 127888232
• Report Number: 9616099-2018-02489
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034050
• 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,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 466F220AF
• Device Lot Number: 17666027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• 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