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

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

(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.Please note that the device associated with the reported event is not sold in the us but is similar to other pta catheters manufactured by cordis.

Event Description

After opening the packaging of a 7f maxi ld 110 20x40 percutaneous transluminal angioplasty (pta) catheter, the user found the inner sterile packaging was ¿leaking¿.The device will be returned for analysis.The leaking was found during preparation of the device.The product was not purposely opened in anticipation of use, and when not used was reshelved.The damage was noticed prior to using.There was no damage to the product.

Manufacturer Narrative

After opening the packaging of a 7f 20x40mm 110cm maxi ld percutaneous transluminal angioplasty (pta) catheter, the user found the inner sterile packaging was ¿leaking.¿ the device will be returned for analysis.The leaking was found during preparation of the device.The product was not purposely opened in anticipation of use, and when not used was reshelved.The damage was noticed prior to using.There was no damage to the product.One non-sterile units of maxi ld pta f7 110 20x40 was received coiled inside a plastic bag, neither the inner pouch nor the outer package was received for analysis.Per visual analysis of received unit, the balloon was not inflated/deflated.Additionally, the body of the device received was found kinked at 27.5cm, at 63.5cm, at 85.2cm and at 94.8cm from the distal end.No other issues were observed.The dimensional analysis to measure seal width was not performed since the product inner pouch was not received for analysis.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 device since the product¿s inner pouch was 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 analysis 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.

• 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: 7801701
• MDR Text Key: 117839136
• Report Number: 9616099-2018-02332
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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: 08/10/2018
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1