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	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt, visual examination revealed a severe kink at the proximal balloon bond and surface scratches on the balloon.Microscopic visual inspection revealed a rupture in the middle of the balloon, approximately 48mm from the distal marker band.The rupture was examined under magnification and was measured to be approximately 1.38mm long.Functional testing determined the balloon was unable to be fully inflated, due to the material rupture.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.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis confirmed the material rupture in 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.Although requested, patient weight was unavailable.In the physician¿s opinion, the highly calcified lesion caused the material rupture.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 6 atmospheres (atms.) while treating a highly calcified vessel in the distal superficial femoral artery (sfa).The health care professional (hcp) used a contralateral approach to gain patient access with a 7 french terumo destination introducer sheath.It is unknown if the hcp predilated the target lesion.No stents were noted to be present.The hcp reportedly inflated the lutonix dcb to 6 atms and the balloon burst.The hcp successfully removed the lutonix dcb and used a mustang percutaneous transluminal angioplasty (pta) balloon to complete the procedure.In the physician¿s opinion, the highly calcified lesion caused the material rupture.The lutonix dcb was requested for return to complete an 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: 6425557
• Report Number: 3006513822-2017-00050
• Device Sequence Number: 13682023
• Product Code: ONU
• UDI-Device Identifier: 00801741105012
• UDI-Public: (01)00801741105012(17)181004(10)GFAX3297
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

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: 10/04/2018
• Device Model Number: 9004
• Device Catalogue Number: BSCLX351305150
• Device Lot Number: GFAX3297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR