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	01/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt, visual examination was performed over the entire length of the catheter revealing no evidence of damage to the catheter.Microscopic visual inspection noted a longitudinal rupture extending from the proximal end of the balloon to the middle of the balloon.Deep scratches perpendicular to the longitudinal rupture were noted, possibly due to calcification at the target lesion.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.Conclusion: returned product analysis confirmed the material rupture to be longitudinal in nature at the proximal end, extending to the middle of the balloon.Additional scratches perpendicular to the longitudinal rupture were present.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.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.Actual device evaluated.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured during treatment of a calcified, non-tortuous right popliteal artery.The health care professional (hcp) reportedly advanced the lutonix dcb to the target lesion within the popliteal artery and incrementally inflated the balloon to 7 atmospheres, at which point the balloon allegedly ruptured.The lutonix dcb was removed completely without issues and another lutonix dcb was used to complete the procedure.The lutonix dcb was 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: 5442839
• Report Number: 3006513822-2016-00009
• Device Sequence Number: 16186784
• Product Code: ONU
• UDI-Device Identifier: 00801741088605
• UDI-Public: (01)00801741088605(17)170806(10)GFZH1223
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/19/2016

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: 08/06/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130660
• Device Lot Number: GFZH1223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 82