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

Model Number	9004
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt, visual inspection revealed a longitudinal rupture in the balloon material at the distal marker band extending approximately 22mm in length to the middle of the balloon.The distal and proximal ends of the longitudinal rupture were perpendicular to the length of the balloon, creating a wide "u" shape.The distal and proximal curves of the "u" are jagged in nature.Functional testing confirmed the balloon was not able to maintain pressure.A device history record review was not able to be performed, as the lot number was not provided by the user facility.Conclusion: returned product analysis was able to confirm a longitudinal rupture in the balloon material, which was unable to maintain pressure.Based on the information provided and analysis results, a definitive root cause was not able to be determined.It should be noted the in stent lesion in the common femoral artery, not an approved indication for use, was not predilated prior to inflating the lutonix dcb catheter and may have contributed to the event.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 6 atmospheres (atms) while treating the in-stent target lesion of the distal left common iliac artery.The health care professional (hcp) used a contralateral approach to gain patient access.The hcp did not predilate the in-stent target lesion.The stent was intact and did not appear to be fractured.The hcp reportedly advanced the lutonix dcb to the target lesion in the zilver ptx stent, and inflated the balloon to 6 atms.After the lutonix dcb allegedly ruptured, reportedly it was removed in its entirety without difficulty.The hcp completed the procedure with another lutonix dcb.In the opinion of the hcp, the inflation within the zilver stent was related to the nature of the rupture.The lutonix dcb was returned for evaluation.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: 8573861
• Report Number: 3006513822-2019-00065
• Device Sequence Number: 381339
• Product Code: ONU
• UDI-Device Identifier: 00801741123252
• UDI-Public: (01)00801741123252
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/02/2019

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 Model Number: 9004
• Device Catalogue Number: LX351306405F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 61