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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 AB35W06040080V02
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 has reported that the labelling on the inner and outer packaging indicates that the evercross pta balloon catheter is 6mm x 40mm. The device in the packaging is actually 6mm x 120mm. Evaluation summary: the evercross 0. 035in otw pta dilation catheter was received in its transportation hoop which was within its sealed pouch, in the shelf carton. The labeling for the shelf carton and pouch indicate that the device is a 06mm x 40mm x 80cm. The printed strain relief on the device indicates that it is a 6mm x 120mm.
 
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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 Key5100453
MDR Text Key26864680
Report Number2183870-2015-00334
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K110319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 04/01/2014
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 NumberAB35W06040080V02
Device Catalogue NumberAB35W06040080V02
Device Lot Number9855291
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2014
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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