MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA 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	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter, which a material rupture was present in the middle portion of the balloon approximately 79 mm from the distal marker band.Under microscopic evaluation (10x-30x), a longitudinal material rupture was found to be in a "z" shape.The length of the "z" shaped rupture was approximately 0.5 mm.Distal to the "z" shaped material rupture, is a significant scratch.The length of the scratch is approximately less then 0.5 mm.The hcp predilated the heavily calcified target lesion.The lutonix dcb was prepared by establishing negative pressure and removing the balloon protector without issues.The hcp reported no noticeable defects of the lutonix dcb catheter.After predilation, the hcp advanced the lutonix dcb to the target lesion through a previously placed stent in the proximal sfa.Lot history review revealed this is the only complaint associated with the corporate lot number gfcx3313.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis confirmed a longitudinal "z" shaped material rupture present in the middle portion of the balloon.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The health care professional (hcp) reported the target lesion was heavily calcified and the pathway to the target lesion contained a previously placed stent.Therefore, the known information from the hcp and the returned sample provides both confirmation of the reported event, and leads to the possibility that the longitudinal "z" shaped material rupture is likely consistent with use in a heavily calcified 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 failed to inflate when attempting to treat the left superficial femoral artery (sfa).The health care professional (hcp) used a contralateral approach to gain patient access with a 6 french cook introducer sheath over an 018 terumo guidewire.The hcp predilated the heavily calcified target lesion.The lutonix dcb was prepared by establishing negative pressure and removing the balloon protector without issues.The hcp reported no noticeable defects of the lutonix dcb catheter.After predilation, the hcp advanced the lutonix dcb to the target lesion through a previously placed stent in the left proximal sfa.The hcp used an inflation device, but the lutonix dcb balloon would not inflate.The hcp used another lutonix dcb to complete the procedure.The lutonix dcb was returned for evaluation and a material rupture was discovered.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: 8597501
• Report Number: 3006513822-2019-00074
• Device Sequence Number: 2042520
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/09/2019

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: 12/07/2021
• Device Model Number: 9004
• Device Catalogue Number: LX3513061505F
• Device Lot Number: GFCZ0298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 65