MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD; ULTRAVERSE 035 PTA DILITATION CATHETER

Model Number U3513084

Device Problems Material Rupture (1546); Component Missing (2306); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 03/03/2017

Event Type  malfunction  

Event Description

Procedure was endoscopic repair of type ia endoleak ia endovascular aortic aneurysm repair proximal aortic cuff and bilateral renal snorkeling, left iliac limb stenting, uv ultrasound, and left brachial artery exposure and repair.At the conclusion of the procedure the surgeon attempted to dilate the left renal artery using the balloon device, but when attempting to deflate, the balloon ruptured causing the tip to disintegrate when it was pulled back into the sheath.Once removed it was noted that the tip and distal marker were missing.Following examination the distal marker was located and removed.The balloon tip could not be accounted for and is not radiopaque, so could not be located despite attempts to do so.One of the items listed is the defective product.Because two of these items were on the sterile field, it was not possible to determine which item was defective since we could not find any lot number identifier on either product once out of the packaging.Second product information: same product identifiers: lot #5013994, exp date 05/30/2017.

• Brand Name: BARD
• Type of Device: ULTRAVERSE 035 PTA DILITATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• MDR Report Key: 6427374
• MDR Text Key: 70815926
• Report Number: MW5068595
• Device Sequence Number: 2
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2017
• Device Model Number: U3513084
• Device Lot Number: 5013994
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 83 YR