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

Model Number	9004
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not returned to the user facility; therefore, 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) shows the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.If additional information becomes known to the manufacturer, a supplemental report will be provided will 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, during preparation, was allegedly punctured while removing the balloon protector.The health care professional (hcp) used a contralateral approach to gain patient access using a 6 french ansel introducer sheath and a 260 cook roadrunner guidewire.The hcp loaded the lutonix dcb onto the guidewire without removing the balloon protector.Reportedly, the hcp did not apply negative pressure to the balloon prior to or during the attempted balloon protector removal.Allegedly, the surgical tech possibly did not pinch the opposite side of the balloon protector when peeling.Reportedly, the hcp advanced the lutonix dcb to the introducer sheath hemostasis valve, and then removed the balloon protector, just prior to inserting the device.Reportedly, while removing the balloon protector the balloon was unknowingly damaged.In the opinion of the hcp, the damage was a longitudinal puncture in the balloon and not related to the patient's anatomy.Allegedly, the balloon was inserted into the patient and successfully advanced to the target lesion.Reportedly, the hcp proceeded to inflate the balloon, but the balloon failed to inflate.The hcp removed the balloon without difficulties and used another lutonix dcb of the same size to successfully treat the target lesion.The lutonix dcb is requested to be returned for evaluation.No 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: 6576808
• Report Number: 3006513822-2017-00097
• Device Sequence Number: 1088773
• Product Code: ONU
• UDI-Device Identifier: 00801741123290
• UDI-Public: (01)00801741123290(17)180721(10)GFAU1833
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513061205F
• Device Lot Number: GFAU1833
• 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: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 69