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

Model Number	9010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample was discarded at the user facility; 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) review was performed and noted the device was manufactured to specification prior to being released for distribution.Conclusion: the actual sample was not received for evaluation.The hcp reported the lutonix dcb ruptured at nominal pressure while treating the target lesion in the av fistula.Although requested multiple times, additional event details and patient demographics are unavailable.If additional information is received, 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 ruptured at nominal pressure while treating the target lesion in the av fistula.The health care professional (hcp) discarded the lutonix dcb and it is not available for evaluation.Although requested multiple times, additional event details and patient demographics are unavailable.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: 8023835
• Report Number: 3006513822-2018-00244
• Device Sequence Number: 13798530
• Product Code: PRC
• UDI-Device Identifier: 00801741135385
• UDI-Public: (01)00801741135385
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• 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): 10/31/2018

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: 04/19/2021
• Device Model Number: 9010
• Device Catalogue Number: LX3575640V
• Device Lot Number: GFCR1922
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1