MAUDE Adverse Event Report: PLYMOUTH EVERCROSS; CATHETER, PERCUTANEOUS

Model Number AB35W06120135

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien plymouth location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.(b)(4).

Event Description

The customer reports that the packaging states 6mm x 120mm x 135mm evercross pta balloon catheter, however, the actual device was 6mm x 40mm x 80mm.Evaluation summary: the device was returned packed in its pouch and shelf carton.Examination of the shelf and pouch labels matches the labels in the shop-floor paperwork for lot number 9855406 work order.The device balloon chamber was in a pre-inflation profile tightly wrapped or winged and covered by its balloon protector.The strain relief was examined: it indicated that the balloon was a 6mm diameter by 40mm length: lot number 9855406 paperwork and labeling state that the balloon should be 6mm diameter by 120mm length balloon.The working length of the returned dilation catheter was approximately 80cm: lot number 9855406 paperwork and labeling state that the working length should be 135cm.

• Brand Name: EVERCROSS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5100517
• MDR Text Key: 26862377
• Report Number: 2183870-2015-00335
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2017
• Device Model Number: AB35W06120135
• Device Catalogue Number: AB35W06120135
• Device Lot Number: 9855406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1489-2014
• Patient Sequence Number: 1