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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLYMOUTH EVERCROSS CATHETER, PERCUTANEOUS

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PLYMOUTH EVERCROSS CATHETER, PERCUTANEOUS Back to Search Results
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.
 
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Brand NameEVERCROSS
Type of DeviceCATHETER, 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 Key5100517
MDR Text Key26862377
Report Number2183870-2015-00335
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 03/20/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/16/2017
Device Model NumberAB35W06120135
Device Catalogue NumberAB35W06120135
Device Lot Number9855406
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1489-2014

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