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

Model Number	9004
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8392922
• Report Number: 3006513822-2019-00040
• Device Sequence Number: 1576271
• Product Code: ONU
• UDI-Device Identifier: 00801741123320
• UDI-Public: (01)00801741123320
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 75