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

Model Number 104-4112

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.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 treatment, on inflation process the balloon was broken before to get the diameter expected.

Manufacturer Narrative

The device was returned for evaluation and the clinical observation could not be confirmed.Upon receipt of the device, there were no damages found with the occlusion balloon catheter hub, body, or distal tip.During evaluation, an attempt was made to flush the occlusion balloon catheter with water, but it was found to be occluded and the cause is likely due to the dried contrast inside.The balloon subassembly was separated (cut) from the catheter body in order to test the balloon for inflation and a leak was found distal to the distal marker band.Upon examination, a defect (hole) was found in the balloon chronoprene tubing.Based on the returned device evaluation, there was no rupture found on the balloon catheter; however, the device evaluation showed the balloon could not maintain inflation due to the defect (hole) in the chronoprene tubing.The defect observed is more consistent with mechanical or navigation related damages rather than those caused by over-inflation (rupture).The customer reported that the balloon was successfully tested prior to use in the patient; therefore, the damage likely occurred during the procedure.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: HYPERGLIDE
• 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: 7660079
• MDR Text Key: 113193787
• Report Number: 2029214-2018-00597
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K021066
• 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: 09/12/2018

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: 11/11/2019
• Device Model Number: 104-4112
• Device Lot Number: A494072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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
• Patient Age: 47 YR