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

Model Number	9004
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Torn Material (3024)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 7033354
• Report Number: 3006513822-2017-00289
• Device Sequence Number: 16619717
• Product Code: ONU
• UDI-Device Identifier: 00801741123283
• UDI-Public: (01)00801741123283
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 11/15/2017

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
• Operator of Device: 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
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 80 YR