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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.
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Manufacturer (Section D)
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
mary haufek
4600 nathan lane north
plymouth, MN 55442
MDR Report Key5100595
MDR Text Key26915808
Report Number2183870-2015-00333
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 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 NumberAB35W06120135
Device Catalogue NumberAB35W06120135
Device Lot Number9855406
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2014
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 Manufactured01/18/2014
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