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

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.

• Brand Name: ENTEER RE-ENTRY BALLOON CATHETER
• Type of Device: CATHETER, 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 Key: 5338650
• MDR Text Key: 35255309
• Report Number: 2183870-2015-07628
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K120129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENB-375-20-135
• Device Catalogue Number: ENB-375-20-135
• Device Lot Number: A128497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1