MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD PTA F7 110 20X40; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing telephone and fax numbers of cordis cashel are respectively, (b)(4).The device was returned but the engineering report is pending.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.This is one of two products associated with the reported event but the related report number is not currently available.

Event Description

After opening the packaging of 2 7f maxi ld 110 20x40 percutaneous transluminal angioplasty (pta) catheters, the user found the inner sterile packaging was ¿leaking.¿ the devices will be returned for analysis.There was no reported patient injury.When removing the package, it was noted that the inner package leaked before being used.The seal of the inner package was not was opened.The product was stored in the lab.The actual product was not damaged.The product was not used.

Manufacturer Narrative

After opening the packaging of 2 7f maxi ld 110 20x40 percutaneous transluminal angioplasty (pta) catheters, the user found the inner sterile packaging was ¿leaking.¿ there was no reported patient injury.When removing the package, it was noted that the inner package leaked before being used.The seal of the inner package was not opened.The product was stored in the lab.The actual product was not damaged.The product was not used.Case-(b)(4): two non-sterile unit of maxi ld pta f7 110 20x40 were received coiled inside a plastic bag.No original inner/outer packaging was returned for analysis.The device identified as number 1 was assigned to this product evaluation file.Device # 1 was visually inspected and several kink/bent conditions were observed at 24, 54, 86 and 88 cm from the distal tip.No other damages or anomalies were found.A device history record (dhr) review of lot 17705610 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 compromised sterility sterile barrier breached¿ could not be confirmed through analysis of the returned devices since the products¿ inner pouches were not received.The exact cause of the issue experienced by the customer could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the issue experienced by the customer.However, the kinked conditions found may be due to handling during shipping for analysis since none of the packaging was received.As warned in the instructions for use, which is not intended as a mitigation, ¿do not use open or damaged packages.¿ neither the product analyses nor the dhr reviews suggests that the event reported could be related to the manufacturing process.Therefore, no corrective/preventive actions will be taken at this time.This is one of two products associated with the reported event and the related report number is 9616099-2018-02396.

• Brand Name: MAXI LD PTA F7 110 20X40
• Type of Device: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 7885345
• MDR Text Key: 120704277
• Report Number: 9616099-2018-02395
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K023907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 4162040L
• Device Lot Number: 17705610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1