MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD PTA F7 110 20X40; DILATOR, ESOPHAGEAL

Model Number 4162040L

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

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

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after opening the package for a maxi ld balloon catheter (pta f7 110 20x40), it was found that the inner sterile packaging was leaked.There was no patient injury reported.The device will be returned for analysis.Devices are stored in the lab according to the ifu.No damage was noted to the outer packaging.The integrity of the sterile pouch was compromised.It is not possible that the product had been purposely opened in anticipation of use, and when not used was reshelved.The actual product was not damaged.The product was not used.

Manufacturer Narrative

Complaint conclusion: after opening the packaging of a 7f 20x40mm 110cm maxi ld percutaneous transluminal angioplasty (pta) catheter, it was found that the inner sterile packaging was ¿leaked.¿ there was no patient injury reported.The device will be returned for analysis.Devices are stored in the lab according to the ifu.No damage was noted to the outer packaging.The integrity of the sterile pouch was compromised.It is not possible that the product had been purposely opened in anticipation of use, and when not used was re-shelved.The actual product was not damaged.The product was not used.A non-sterile unit of maxi ld pta f7 110 20x40 was received coiled inside a plastic bag.No original inner/outer packaging was returned for analysis.The balloon was received inside the protective tube.No other anomalies were found on the device.A device history record (dhr) review of lot 17711136 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.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: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7842352
• MDR Text Key: 119803466
• Report Number: 9616099-2018-02362
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• 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: 4162040L
• Device Catalogue Number: 4162040L
• Device Lot Number: 17711136
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1