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

Model Number 466F210A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

The packaging of a optease retrieval 55cm catheter was found damaged after it was opened.The outer packaging was broken.The damage was noted upon initial receipt of the product.The product was not used.There was no reported patient injury.The device was stored as per the instruction for use.The product was returned for analysis.Per visual analysis of the picture received, a torn on the carton of the outer box package was observed on the front side of the unit.The connector of the stopcock valve was protruding through the outer box package of the unit.The two inner package pouches of the optease retr filter 55 were received for analysis folded inside a plastic bag.However, the outer box of the device was not returned for analysis.Per visual analysis of the returned pouches, no anomalies were found on the pouch package containing the retrievable vena cava filter set components.The pouch package containing the brite tip csi and vessel dilator components was received frayed/split/torn damaged.The connector of the stopcock valve was observed protruding through the film material of the pouch at the label level.No other anomalies were found.A product history record (phr) review of lot 17868949 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box- frayed/split/torn - outer box¿ and ¿packaging/pouch/box- frayed/split/torn - inner package¿ were confirmed due to the confirmed protruding condition of the stopcock through one of the unit¿s pouches.However, the protruding condition observed could not be conclusively determined during the analysis.Shipping and /or handling factors may contribute to the failure as reported.According to the instructions for use, which are not intended as a mitigation of risk, ¿ remove the retrieval catheter from its packaging using sterile technique.Inspect the retrieval catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a retrieval catheter that has been damaged in any way.If damage is detected, replace with an undamaged retrieval catheter¿.Neither the phr review analysis nor the product analysis results do not suggest that the observed stopcock protruding condition is related to the manufacturing process of the unit therefore, no corrective or preventative actions will be taken at this time, given that the reported and observed damages do not appear to be related to the manufacturing process.

Event Description

As reported, the packaging of 55cm optease retrieval catheter was found damaged after it was opened.According to the image provided of the device, the outer box of the device appears to be torn.Per the manufacturer product evaluation of the returned device, the pouch package containing the brite tip csi and vessel dilator components was received with frayed/split/torn damaged.The connector of the stopcock valve was observed protruding through the film material of the pouch at the label level.There was no reported patient injury.The outer packaging was broken.The damage was noted upon initial receipt of the product.The product was not used.The device was stored as per the instruction for use.The device will be returned for evaluation.An image is available for review.

• Brand Name: OPTEASE RETR FILTER 55
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9437303
• MDR Text Key: 199105851
• Report Number: 9616099-2019-03389
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• 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: 466F210A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17868949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• 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