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

Model Number	9004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample was discarded at the user facility; therefore, an evaluation was 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.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: the actual sample was not returned for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.Reportedly, the hcp prepared the highly calcific target lesion with atherectomy followed by a scoring balloon for pre-dilatation.Allegedly, the hcp inflated the lutonix dcb to 12 atms for a minute and a half when reportedly it ruptured, a pinhole rupture.In the opinion of the hcp, he definitely believes the balloon ruptured due to the highly calcified lesion.However, the lack of the returned sample prevents both confirmation of the reported event and identification of a root cause(s), but based on the reported information it is possible the rupture is consistent with the hcp's method of vessel preparation and the calcified nature of the target lesion.If additional information becomes available, 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 while being inflated to 12 atmospheres (atms) in the highly calcified target lesion of the right distal superficial femoral artery (sfa) and proximal popliteal artery.The health care professional (hcp) used a retrograde approach through the right common femoral artery with a 6 french introducer sheath (brand unknown) over an 018 guidewire (brand unknown).Reportedly, the hcp prepared the calcified target lesion with atherectomy followed by a scoring balloon for pre-dilatation.The hcp removed the balloon protector without issues, but it is unknown if negative pressure was applied during advancement to the target lesion.Allegedly, the hcp inflated the lutonix dcb to 12 atms for a minute and a half when reportedly it ruptured, a pinhole rupture.In the opinion of the hcp, he definitely believes the balloon ruptured due to the highly calcified lesion.The lutonix dcb was discarded by user facility and is not available for evaluation.No adverse patient outcomes were reported.

• Brand Name: LUTONIX 035 DRUG COATED PTA BALLOON CATHETER
• Common Device Name: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8579368
• Report Number: 3006513822-2019-00066
• Device Sequence Number: 1638679
• Product Code: ONU
• UDI-Device Identifier: 00801741123283
• UDI-Public: (01)00801741123283
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/03/2019

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 Expiration Date: 04/19/2021
• Device Model Number: 9004
• Device Catalogue Number: LX3513061005F
• Device Lot Number: GFCR1741
• Was Device Available for Evaluation?: No
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR