MAUDE Adverse Event Report: C.R. BARD, INC. LUTONIX DRUG COATED BALLOON

Catalog Number BSCLX351306100

Device Problems Detachment Of Device Component (1104); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2015

Event Type  malfunction  

Event Description

During angioplasty of patient's left superficial femoral artery, drug coated balloon was deployed in patient's superficial femoral artery.Second inflation in a different location in the artery after initial pta was performed; however, technologist and vascular surgeon noticed sound of air coming from connection hub between inflation port and balloon catheter.The balloon would not properly inflate during this second inflation, only come partially up but would not stay inflated.Attempts were made with insufflator to aspirate air and no air returned in device.Initially tech and md thought balloon may have burst, but no air would return even with manual aspiration with a syringe.Attempt was made to remove balloon out of patient while keeping wire access in patient, and balloon would not move.Guidewire could be moved, but not catheter.Attempt was made to remove both guidewire and balloon catheter, however it would attempt to take the access sheath out.At this point, dr.Felt it was not safe to continue the procedure.Patient was awakened and informed by dr.That he would need to take the patient to surgery for femoral endarterectomy and open removal of balloon catheter.Manufacturer response for drug coated balloon, lutonix (per site reporter): just notified the boston/bard rep yesterday after occurrence.No response yet.

• Brand Name: LUTONIX DRUG COATED BALLOON
• Type of Device: DRUG COATED BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 5180013
• MDR Text Key: 29316412
• Report Number: 5180013
• Device Sequence Number: 1
• Product Code: ONU
• 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: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: BSCLX351306100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR