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	05/17/2017
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.Under magnification, it was observed the balloon had a longitudinal material rupture in the middle of the balloon to the distal balloon bond.Functional testing determined the balloon was unable to be inflated due to the large longitudinal material rupture.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.Conclusion: returned product analysis confirmed the material rupture to be a longitudinal rupture in the middle of the balloon to the distal balloon bond.There was nothing found to indicate there was a manufacturing related cause for this event.The physician reported the lutonix dcb was inflated within a previously placed stent.If additional information becomes available, a supplemental 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 4 atmospheres while being inflated within a previously placed stent.The health care professional (hcp) used a contralateral approach through the common femoral artery to gain access to the patient's superficial femoral artery (sfa).The hcp used a 6 french terumo pinnacle destination introducer sheath over a terumo guidewire.The target lesion was reported predilated with a 5x150 cordis powerflex.Reportedly, the target lesion was not calcified or tortuous.The lutonix dcb was requested to be 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: 6642615
• Report Number: 3006513822-2017-00120
• Device Sequence Number: 707285
• Product Code: ONU
• UDI-Device Identifier: 00801741123245
• UDI-Public: (01)00801741123245(17)200118(10)GFBN0489
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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: 01/18/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFBN0489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 98