MAUDE Adverse Event Report: BARD ULTRAVERSE; ULTRAVERSE PTA DILITATION CATHETER

Catalog Number U35130610

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 09/07/2017

Event Type  Injury  

Event Description

An ultraverse 6.0mmx100mm balloon was fed into place and the distal area was treated without any problems.The balloon burst on the second inflation.When it was retrieved the tip and part of the balloon were missing.Under fluoroscopy, dr.(b)(6) identified a piece of the balloon against the vessel wall.A 6x4 self-expanding stent was placed to trap the balloon.

• Brand Name: ULTRAVERSE
• Type of Device: ULTRAVERSE PTA DILITATION CATHETER
• Manufacturer (Section D): BARD; tempe AR
• MDR Report Key: 6862535
• MDR Text Key: 86102072
• Report Number: 6862535
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: U35130610
• Device Lot Number: CMAX0128
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2017
• Distributor Facility Aware Date: 09/07/2017
• Date Report to Manufacturer: 09/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR