MAUDE Adverse Event Report: COVIDIEN (IRVINE) HYPERFORM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4770

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.The device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device and/or additional information a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the procedure, hyperform burst during inflation.There were not any patient symptoms or complications associated with this event.No patient injury was reported.

Manufacturer Narrative

The device was returned for evaluation and the clinical observation could not be confirmed.As received, there was not any issues or irregularities were found with the occlusion balloon catheter hub, body or distal tip.The occlusion balloon catheter was flushed with water and water exited from the distal tip.During evaluation, inflation test of balloon was performed with mandrel inserted into the distal tip of the balloon.An unsuccessful attempt was made to inflate the balloon as it was found to be leaking distal to the distal marker band.Upon microscopic examination, a defect (tear) in the chronoprene tubing was found at the location of the leak.No ¿ruptures¿ were found with the balloon.Based on the device evaluation event did not meet the reporting criteria.The balloon could not maintain inflation due to the defect (tear) in the chronoprene tubing.The defect observed is consistent with mechanical or navigation related damage rather than those caused by over-inflation (rupture).All balloons are 100% leak tested and all devices are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYPERFORM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7407637
• MDR Text Key: 104917381
• Report Number: 2029214-2018-00260
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K011656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2018
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: A403644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2017
• 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