MAUDE Adverse Event Report: BARD VACCESS ANGIOPLASTY BALLOON; ANGIOPLASTY BALLOON/ CATHETER ANGIOPLASTY

Catalog Number VA80104

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104); Fracture (1260); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 02/13/2018

Event Type  Injury  

Event Description

The 10 x 40 mm vaccess angioplasty balloon (bard incorporated) tore during 3rd inflation at 8 atm while treating three venous stenosis that had been previously stented.No inflation exceeded rated burst pressure of 15 atm.Balloon tore circumferentially, rather than longitudinally, so its central half could not be removed via 6 fr sheath, or via the access with sheath removed.Central half of balloon crumpled against fistula wall with traction on the catheter.Via two new accesses occlusive balloons were placed to isolated fractured balloon from blood stream and prevent emboliation.Initial access was enlarged and after it detached from catheter body, balloon fragment still attached to catheter tip was extracted with forceps.Surgical wound closed with dissolvable suture.Stenoses successfully treated angiographically.Fistula patent immediately following procedure.

• Brand Name: VACCESS ANGIOPLASTY BALLOON
• Type of Device: ANGIOPLASTY BALLOON/ CATHETER ANGIOPLASTY
• Manufacturer (Section D): BARD; tempe AZ 85281
• MDR Report Key: 7276106
• MDR Text Key: 100421242
• Report Number: MW5075287
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741121258
• UDI-Public: 0100801741121258
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2021
• Device Catalogue Number: VA80104
• Device Lot Number: 93NC0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 104