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

Model Number	9004
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample disposition at the user facility is unknown; therefore, an evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with removal difficulty resulting in torn material for this lot.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The health care professional (hcp) reported difficulty removing the lutonix dcb after successful treatment of the target lesion resulting in the balloon shearing off the catheter shaft while the balloon was in the introducer sheath.The balloon was fully contained in the introducer sheath; thus, no foreign material is present in the patient at the conclusion of the procedure.Based on the information obtained related to the event and the investigation, a definite root cause cannot be determined.It is unknown if procedural issues contributed to the reported event.If additional information becomes known to the manufacturer, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was difficult to remove from the patient after treating the target lesion in the left lower extremity.The health care professional (hcp) encountered difficulty removing the lutonix dcb after treatment.The introducer sheath (brand unknown) and the guidewire (brand unknown) along with the catheter were removed as a single unit.The hcp provided manual compression to the patient's access site after the equipment was removed.The physician noted the balloon portion of the lutonix dcb was sheared off and fully contained inside the introducer sheath.Reportedly, the hcp confirmed no foreign bodies were left in the patient.The lutonix dcb, along with the introducer sheath, were requested to be returned for evaluation, but the sample disposition is unknown at tis time.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: 7677134
• Report Number: 3006513822-2018-00160
• Device Sequence Number: 13821735
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: 12/01/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513061505F
• Device Lot Number: GFBY3509
• 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: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1