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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of the sample, visual examination was performed over the entire length of the catheter and no damage was evident.Functional testing determined the balloon was unable to be inflated due to a material rupture in the middle of the balloon.Under magnification, the material rupture was a hole with material overflapping outwardly, which is associated with an object of unknown origin piercing the middle of the balloon.Although requested, it is unknown if the pathway to the target lesion or the lesion itself was calcified or tortuous.A lot history review revealed this is the only complaint associated with balloon 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.Although requested, patient demographics were unknown at the time of this report.Returned product analysis confirmed the material rupture was related to an object of unknown origin piercing the middle of the balloon.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause for the rupture could not be determined.It is unknown if procedural issues contributed to the reported event.If additional information becomes available, a supplement report will be submitted with all relevant information.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at four atmospheres (atms) during the treatment of the target lesion.The health care professional (hcp) gained patient access to treat the superficial femoral artery (sfa).The hcp prepared the lutonix dcb in the normal fashion and removed the balloon protector without issues.It is unknown if the pathway to the target lesion or the lesion itself was calcified or tortuous.The hcp used another balloon to treat the target lesion successfully.The lutonix dcb was requested to be returned for further evaluation.No adverse patient effects 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: 6095518
• Report Number: 3006513822-2016-00203
• Device Sequence Number: 10972957
• Product Code: ONU
• UDI-Device Identifier: 00801741123269
• UDI-Public: (01)00801741123269(17)180429(10)GFAR3876
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2016

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: 04/29/2018
• Device Model Number: 9004
• Device Catalogue Number: LX351306605F
• Device Lot Number: GFAR3876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1