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	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed multiple kinks with the first between 122-123 geomarker, between 92-93 geomarker, between 83-84 geomarker, between 42-43 geomarker, and a kink 31mm from the proximal balloon bond.The distal balloon bond was slightly wrinkled.The returned balloon was not completely deflated.Functional testing of the returned sample revealed a leak in the distal area of the balloon.Under magnification(10-30x), the material rupture was longitudinal in nature, perpendicular to the length of the balloon in the distal area of the balloon.Furthermore, multiple scratches on the surface of the balloon were surrounding the rupture location.A lot history review revealed this is the only complaint associated with material 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.Conclusion: returned product analysis confirmed a material rupture which was longitudinal in nature, perpendicular to the length of the balloon, in the distal area of the balloon.Furthermore, multiple scratches on the surface of the balloon were surrounding the rupture location.There was nothing found to indicate there was a manufacturing related cause for this event.The hcp did not predilate the calcified target lesion per the instructions for use (ifu).Additionally, the hcp believes the calcification of the target lesion is likely related to the nature of the material rupture.A calcified target lesion, which was not predilated, likely contributed to the reported event.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 was unable to inflate due to a material rupture while treating the calcified target lesion between the superficial femoral artery(sfa) and the tibio-peroneal trunk.The health care professional (hcp) used an ipsilateral approach to gain patient access.The hcp did not predilate the calcified target lesion.The hcp believes the calcification of the target lesion is likely related to the nature of the material rupture.The hcp used another device to successfully complete the patient's procedure.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: 7310715
• Report Number: 3006513822-2018-00042
• Device Sequence Number: 19174518
• Product Code: ONU
• UDI-Device Identifier: 00801741123191
• UDI-Public: (01)00801741123191
• 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: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: 09/30/2019
• Device Model Number: 9004
• Device Catalogue Number: 9090413500040
• Device Lot Number: GFAV3316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 69