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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ENTEER RE-ENTRY BALLOON CATHETER CATHETER, PERCUTANEOUS

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COVIDIEN ENTEER RE-ENTRY BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number ENB-375-20-135
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2015
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacture records for this device is ongoing. Once the evaluation is complete a supplemental report will be submitted. (b)(4).

 
Event Description

During the procedure the enteer balloon burst. The balloons on the enteer burst when it was inserted a second time and the wire would not re-enter the lumen. The procedure was aborted. The lesion being treated was 100% cto in a 7mm diameter artery. The lesion length was 250mm. The balloon was at 8atm when it burst (it is indicated at 3-4 atms). No injury reported. The physician is planning to bring the patient back another day.

 
Manufacturer Narrative

Evaluation of the returned enteer catheter was completed january 14, 2016. A review of the manufacture records could not be conducted because the lot number provided was not for the enteer device. The enteer catheter was received without the enteer guidewire. The enteer catheter was inspected and found blood within the balloon and catheter shaft of the device. The balloon was inspected under microscope and both guidewire exit ports were undamaged and no signs of obstruction were observed. Both marker bands were intact and accounted for. A test syringe was used to inflate the balloon. A leak was identified at the distal end of the balloon. After flushing the balloon a longitudinal tear was identified. The customer¿s report of a balloon burst has been confirmed. A visual inspection of the balloon identified a longitudinal tear at the distal end of the balloon after being identified during functional testing. The root cause could not be identified.

 
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Brand NameENTEER RE-ENTRY BALLOON CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
COVIDIEN
4600 nathan lane n
plymouth MN 55441
Manufacturer (Section G)
COVIDIEN
4600 nathan lane n
plymouth MN 55442
Manufacturer Contact
mary haufek
4600 nathan lane n
plymouth, MN 55442
7633987000
MDR Report Key5338650
MDR Text Key35255309
Report Number2183870-2015-07628
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK120129
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberENB-375-20-135
Device Catalogue NumberENB-375-20-135
Device LOT NumberA128497
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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