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	11/02/2016
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 proximal end of the balloon was slightly wrinkled and the outer shaft was kinked approximately 54 cm from the strain relief.Under magnification, a 5mm longitudinal tear, located approximately 30 mm from the distal tip of the catheter, was identified.Functional testing of the balloon portion of the catheter was performed by attempting to inflate the balloon.The balloon did not inflate and testing solution began dripping from the longitudinal tear.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 allegation to be longitudinal tear, 5mm long, approximately 30 mm from the distal tip of the catheter.The lutonix 035 drug coated balloon was inflated in a minimally calcified intra-stent stenotic lesion.Note, the lutonix 035 drug coated balloon pta catheter is indicated for percutaneous transluminal angioplasty (pta), after pre-dilatation of de novo or restenotic lesions up to 150 mm in length in the native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.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.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at three atmospheres while treating a minimally calcified intra-stent stenotic lesion.The health care professional (hcp) predilated the target lesion prior to treatment with the lutonix dcb.The lutonix dcb was removed without difficulty.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: 6158517
• Report Number: 3006513822-2016-00213
• Device Sequence Number: 16339645
• Product Code: ONU
• UDI-Device Identifier: 00801741088643
• UDI-Public: (01)00801741088643(17)170630(10)GFZF2510
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/10/2016

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: 06/30/2017
• Device Model Number: 9004
• Device Catalogue Number: 9020413600080
• Device Lot Number: GFZF2510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1