MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER

Model Number	9010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was discarded at the user facility; therefore, an evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with material rupture for this lot.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.There was nothing found to indicate there was a manufacturing related cause for this event.The actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.It was noted the target lesion region was predilated and the pathway to the treatment location was not tortuous.Allegedly, the lutonix dcb ruptured during or immediately after inflation.The hcp reportedly described the material rupture as a pinhole.The lutonix dcb was promptly and safely removed from the patient.Based on the information obtained related to the event and the investigation, a definite root cause cannot 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 bd 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 bd.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating the non tortuous target lesion in the brachiocephalic vein of the av fistula.The health care professional (hcp) gained patient access through the cephalic vein of the av fistula with a 9 (b)(4) cordis introducer sheath over an 035 bentson guidewire.The hcp predilated the target lesion with an atlas 12 x 40 mm percutaneous transluminal angioplasty (pta) balloon.Allegedly, the lutonix dcb ruptured during or immediately after inflation.The hcp reportedly described the material rupture as a pinhole.The lutonix dcb was promptly and safely removed from the patient.Another balloon was used to complete the procedure.The lutonix dcb was discarded by the user facility and is not available for return.No adverse patient outcomes were reported.

• Brand Name: LUTONIX 035AV 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: 8195878
• Report Number: 3006513822-2018-00294
• Device Sequence Number: 10825968
• Product Code: PRC
• UDI-Device Identifier: 00801741135545
• UDI-Public: (01)00801741135545
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• 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): 12/26/2018

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: 05/10/2020
• Device Model Number: 9010
• Device Catalogue Number: LX35751240V
• Device Lot Number: GFCS1215
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 120