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

Model Number 9004

Device Problems Retraction Problem (1536); Material Rupture (1546); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

Analysis: the sample has been retained by the user facility.Lutonix has made several requests for the product to be returned, but the user facility will not release the sample at this time; therefore, an evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with this lot.A device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.Conclusion: although requested, the actual sample was not released from the user facility.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause could not be determined based on the information provided.It is unknown if the patient and/or procedural issues contributed to the reported event.If additional information is received or the sample is returned to the manufacturer, 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.

Event Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 12 atmospheres (atms) while treating a non calcified right common femoral artery (cfa).The health care professional (hcp) used a 5 french cook ansel introducer sheath over an 035 willie guidewire to gain patient access.Allegedly, the hcp did not predilate the target lesion, but was able to advance the lutonix dcb to the target lesion without issues.Reportedly, the hcp inflated the lutonix dcb to 12 atms and the balloon ruptured during the treatment.Upon retraction of the lutonix dcb, the distal tip of the balloon became detached inside the patient's vasculature.It was further reported multiple attempts by the health care provider were made to retrieve the catheter tip using a snare device.The hcp was unsuccessful.The health care provider decided to leave the detached catheter tip in situ, as there was no potential health hazard to the patient.The procedure was concluded, and although requested, it is unknown if further treatment was performed.The lutonix dcb was requested to be returned for evaluation, but the user facility will not release the sample to the manufacturer for inspection.No further adverse patient effects 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: john risse ; 9409 science center dr; new hope, MN 55428 ; 7634632917
• MDR Report Key: 7033354
• MDR Text Key: 92076837
• Report Number: 3006513822-2017-00289
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741123283
• UDI-Public: (01)00801741123283
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513061005F
• Device Lot Number: GFAR3890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2016
• 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; Other
• Patient Age: 80 YR