MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIOVAC; CATHETER, CANNULA & TUBING, VASCULAR

Catalog Number VTX-3022

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2014

Event Type  Injury  

Event Description

As reported, under fluoroscopy, the inner balloon was noted to have burst and the end of the angiovac cannula (outer balloon) was filled with contrast.The case proceeded without incident.The contrast was successfully removed via a percutaneous puncture of the outer balloon at the end of the case.The pt's condition was otherwise unaffected.The used device will not be returned to angiodynamics.

Manufacturer Narrative

The investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

A review of the device history records for the reported lot was performed by (b)(4).The review revealed no abnormalities which could have contributed to the reported event.The angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "balloon leaked/burst - intervention required." no adverse trends were identified.The angiovac cannula sample was not returned for evaluation.Although the root cause of the inner balloon burst issue is unable to be determined, it is potentially a result of the inner balloon bonding process to the cannula shaft.A contributing factor may be over-pressurization of the balloon by the end user.Product enhancements have since revised the balloon material and the bonding process.It cannot be determined if the cannula was used in accordance with its labeling.Directions for use (dfu) is provided with this device and contains the following statements: "adverse affects: this device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel damage and complications of percutaneous or surgical insertion techniques.These may occur if the instructions for use are not followed." (b)(4).Device not returned to manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.; marlborough MA
• Manufacturer (Section G): ANGIODYNAMICS; 26 forest street; marlborough MA 01752
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 3981231
• MDR Text Key: 4821719
• Report Number: 2952363-2014-00004
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VTX-3022
• Device Lot Number: 106711-1
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 07/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention