MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220AF

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)

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

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, an optease filter (retr filter 55 femoral) was prepared for use and inserted into the included sheath.During advancement, the sheath split.It was noted by the physician that the filter may have caught in the sheath causing this issue.There was no patient injury reported.The device was clinically used.

Manufacturer Narrative

Complaint conclusion: as reported, an optease filter (retr filter 55 femoral) was prepared for use and inserted into the included sheath.During advancement, the sheath split.It was noted by the physician that the filter may have caught in the sheath causing this issue.There was no patient injury reported.The device was clinically used.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.The complaint of ¿filter- impeded-perforated sheath¿ as reported by the customer was not confirmed since the involved filter and sheath were not received for analysis.The cause of the events experienced by the customer could not be conclusively determined.Procedural factors, handling process may contribute to the failure as reported.When the filter is passing an acute bend inside the sheath due to vessel tortuosity or if force is applied, the barbs have the potential to perforate the sheath.The ifu instructs ¿to slowly advance the filter into the sheath introduce by advancing the obturator through the end of the storage tube until the filter is positioned well into the cannula of the sheath introducer.If the filter advancement is problematic, advance the sheath introducer to negotiate the curve, and then continue to advance the filter¿.Neither product analysis nor phr review results suggest that these damages found could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: OPTEASE RETR FILTER 55 FEMORAL
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8452674
• MDR Text Key: 139877198
• Report Number: 9616099-2019-02806
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 466F220AF
• Device Catalogue Number: 466F220AF
• Device Lot Number: 17609885
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1