MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COTED BALLOON PTA CATHETER

Model Number 9004

Device Problem Deflation Problem (1149)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Analysis: the sample was retained by the user facility; therefore, evaluation was unable to be performed.Multiple attempts to obtain product identifiers and additional event details were unsuccessful; therefore, a lot history review and a device history record (dhr) were not able to be reviewed for this device.Conclusion: the actual sample was not received for evaluation, but it was retained by the user facility.If additional information is obtained, a supplement report will be submitted with all relevant information.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Actual device not evaluated.

Event Description

It was reported that after treatment with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, allegedly the balloon would not deflate completely.The health care professional (hcp) treated the target lesion and then decided to use the lutonix dcb a second time at an unknown location.The hcp noted when the second inflation was attempted, an air leak from the hub was heard.Reportedly, the balloon would not fully inflate; thus, the hcp attempted to deflate the balloon but it would not fully deflate either.Allegedly, the hcp then attempted to remove the lutonix dcb through the 6 french introducer sheath, but the hub separated from the catheter during retraction.After the hub separation, the catheter started to accordion towards the hemostasis valve of the introducer sheath.The hcp then attempted to remove the introducer sheath and lutonix dcb together, but the balloon was stuck in a highly calcified region of the common femoral artery, just distal to the end of the introducer sheath.The balloon likely became stuck because of the deflation difficulty.The patient was taken to the operating room and a femoral endarterectomy was performed to remove the balloon.The sample is being retained by the facility at this time and is not available for return.No further adverse patient effects were reported.

• Brand Name: LUTONIX 035 DRUG COTED BALLOON PTA CATHETER
• Type of Device: DRUG COTED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 5238052
• MDR Text Key: 31672192
• Report Number: 3006513822-2015-00062
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2015,10/27/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: BSCLX351306100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2015
• Distributor Facility Aware Date: 10/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR