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 07/06/2018

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.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the inner sterile pouch for three maxi balloon catheters (ld pta f7 110 20x40) were found to be leaked.There was no patient injury reported.The devices will be returned for analysis.The device was stored in the lab according to ifu.The sterile barrier was compromised.There was no damage noted to the outer packaging.The actual product was not damaged.The devices were not used.

Manufacturer Narrative

Complaint conclusion as reported, the inner sterile pouch for three maxi balloon catheters (ld pta f7 110 20x40) were found to be leaked.There was no patient injury reported.The devices will be returned for analysis.The device was stored in the lab according to instructions for use (ifu).The sterile barrier was compromised.There was no damage noted to the outer packaging.The actual product was not damaged.The devices were not used.(b)(4): three non-sterile units of maxi ld pta f7 110 20x40 were received coiled inside a plastic bag, the units were identified as unit 1 to 3.The analysis of unit 2 was documented on (b)(4).Per analysis of the unit 2; neither the inner pouch nor the outer package was received for analysis.Per visual analysis, the balloon received was already inflated/deflated.Additionally, the body of the device received was found kinked at 28.4cm, at 34.7cm, at 64.3cm, at 94.5cm, at 96.2cm and at 102.2cm from the distal end.No other issues were observed.The dimensional analysis to measure the seal width could not be performed since the product inner pouch was not received for analysis.A device history record (dhr) review of lot 17654397 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.

• 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: 7740174
• MDR Text Key: 115768000
• Report Number: 9616099-2018-02279
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 4162040L
• Device Catalogue Number: 4162040L
• Device Lot Number: 17654397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Date Manufacturer Received: 07/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1