MAUDE Adverse Event Report: PLYMOUTH EVERCROSS; CATHETER, PERCUTANEOUS

Model Number AB35W06120135

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) 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

It was reported that during procedure, the physician requested a 6x120 evercross pta balloon catheter.The box and package opened was labeled evercross 6 x 120 x 135.The balloon was prepped and inserted into patient.Upon positioning the balloon, the physician noticed that the balloon was much shorter than the 6x120 requested.The physician inspected the balloon and stated that it is labeled 6 x 40.Evaluation summary: the evercross 0.035in otw pta dilation catheter was received for evaluation without any ancillary devices or cine images from the procedure.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 balloon was returned without its shipping hoop and balloon chamber protector.The balloon chamber is in a pre-inflation profile: tightly wrapped or winged.The strain relief indicates that it is a 6mm by 40mm balloon catheter.The distance between the balloon radiopaque markers is consistent with a 40mm balloon.The overall length of the device is approximately 89.5cm from proximal hub to distal tip.

• 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: 5100595
• MDR Text Key: 26915808
• Report Number: 2183870-2015-00333
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• 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: 04/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• 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