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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERCROSS TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER

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COVIDIEN EVERCROSS TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER Back to Search Results
Model Number AB35W07060080
Device Problems Balloon; Burst Container or Vessel ; Detachment of Device or device Component; Tip
Event Date 01/28/2015
Event Type  Injury  
Event Description

The evercross balloon was advanced over aortic bifurcation and inflated to nominal pressure. Upon inflation, the balloon burst and the distal tip of the balloon remained on the wire. The patient was brought to surgery to extract the balloon. The patient is doing well.

 
Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.

 
Manufacturer Narrative

This supplemental 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.

 
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Brand NameEVERCROSS
Type of DeviceTRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie riley
4600 nathan lane n
plymouth , MN 55442
7633987000
MDR Report Key4542218
Report Number2183870-2015-00048
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/10/2017
Device MODEL NumberAB35W07060080
Device Catalogue NumberAB35W07060080
Device LOT NumberA015087
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/11/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/24/2015 Patient Sequence Number: 1
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