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

Model Number 9004

Device Problems Off-Label Use (1494); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual sample was not returned for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.Reportedly, the hcp attempted the first inflation of the lutonix dcb in the left common femoral artery, but the balloon immediately started to loose pressure.The use of a lutonix 035 dcb in the common femoral artery is off-label use.The hcp removed the lutonix dcb from the patient, and reported a pinhole material rupture in the proximal end of the balloon.The lutonix dcb was removed without issues and no associated vessel damage.The lutonix dcb was requested to be returned for evaluation and allegedly the hospital has not released the sample for return.If additional information or the sample is returned to the manufacturer, a supplemental report will be provided with all relevant information.

Event Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly had a pinhole material rupture in the proximal end of the balloon.The health care professional (hcp) used a contralateral approach at the right femoral artery to treat the target lesion in the left common femoral artery.The use of a lutonix 035 dcb in the common femoral artery is not approved per the indications for use (ifu).The hcp used a 45 cm 5 french terumo destination introducer sheath over an 035 cook 360 j-shaped guidewire for patient access.Reportedly, the hcp predilated the target lesion.The hcp prepared the lutonix dcb in the normal fashion and removed the balloon protector without issues.During preparation of the lutonix dcb, the hcp noticed a wrinkle near the proximal end of the balloon.Reportedly, the hcp attempted the first inflation of the lutonix dcb, but the balloon immediately started to loose pressure.The hcp removed the lutonix dcb from the patient, and reported a pinhole material rupture in the proximal end of the balloon.The lutonix dcb was removed without issues and no associated vessel damage.In the opinion of the hcp, the anatomy did not play a factor in the material rupture, but does feel the material rupture was present prior to advancing the lutonix dcb into the patient.The hcp used another device to complete the patients procedure.The lutonix dcb was requested to be returned for evaluation and allegedly the hospital has not released the sample for return.No adverse patient outcomes were reported.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED 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: 8392922
• MDR Text Key: 141476158
• Report Number: 3006513822-2019-00040
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741123320
• UDI-Public: (01)00801741123320
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: 9004
• Device Catalogue Number: LX351307605F
• Device Lot Number: GFCN4098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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 Age: 65 YR
• Patient Weight: 75