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	07/12/2018
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 revealing the middle of the balloon had pinch marks indicating the balloon was held firmly.Under magnification, a small "v" shaped material rupture was found in the distal balloon area, near the marker band.The material rupture was folded within the balloon, at one end.A lot history review revealed one additional complaint is associated with material rupture 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: returned product analysis confirmed a small "v" shaped material rupture was found in the distal balloon area, near the marker band.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.The hcp used a boston scientific v-14 guidewire, which may cause trackabilty issues.The hcp states the vessel was not calcified and prepped with multiple pta balloons.It is unknown if negative pressure was applied during advancement of the lutonix dcb or at what pressure (atm) the balloon was inflated.The procedure was completed with placement of a stent.Many attempts were made by field assurance personnel to get more information, but the user was unable to provide additional event details.A definitive root cause for the rupture could not be determined.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 would not inflate.It was observed a small amount of contrast was coming from the balloon while treating the left superficial femoral artery (sfa).The health care professional (hcp) used a contralateral approach through the right common femoral artery with a 6 french cook flexor flo introducer sheath over a boston scientific v-14 control 014 guidewire.The hcp predilated the non calcified target lesion with a multiple percutaneous transluminal angioplasty (pta) balloons prior to treating the target lesion with a lutonix dcb.The hcp removed the lutonix dcb and completed the procedure with a stent (brand unknown).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: 8054082
• Report Number: 3006513822-2018-00255
• Device Sequence Number: 11087802
• Product Code: ONU
• UDI-Device Identifier: 00801741123245
• UDI-Public: (01)00801741123245
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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: 03/07/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFBQ1423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 69