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	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample was discarded at the user facility; therefore, an evaluation was unable to be performed.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.Reportedly, the hcp did not predilate the target lesion.Although requested, it is unknown if the vessel was calcified or tortuous.The lutonix dcb was removed and a second lutonix dcb was used to complete the procedure.There was nothing found to indicate there was a manufacturing related cause for this 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 ruptured at 9 atmospheres (atms) while treating the target lesion.The health care professional (hcp) used a contralateral approach through the right common femoral artery to treat the left superficial femoral artery (sfa).The hcp did not predilate the target lesion and it is unknown if the vessel was calcified or tortuous.The hcp used a cook flexor 6 french introducer sheath over a terumo 035 glidewire to advance the lutonix dcb to the target lesion.Reportedly, the lutonix dcb was inflated once and the balloon ruptured while attempting to treat the target lesion.The lutonix dcb was removed and a second lutonix dcb 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.
Additional Manufacturer Narrative
Male was added.Additional information added to the event description regarding preparation of the lutonix dcb and negative pressure during advancement."the hcp prepared the balloon in the normal fashion and removed the balloon protector without issues.The hcp used a cook flexor 6 french introducer sheath over a terumo 035 glidewire to advance the lutonix dcb, under negative pressure, to the target lesion." corrected information: was changed from "although requested, patient gender was unavailable." to "unknown".Analysis: the sample was discarded at the user facility; therefore, an evaluation was unable to be performed.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.The actual sample was not received for evaluation.Reportedly, the hcp did not predilate the target lesion.Although requested, it is unknown if the vessel was calcified or tortuous.The lutonix dcb was removed and a second lutonix dcb was used to complete the procedure.There was nothing found to indicate there was a manufacturing related cause for this event.If additional information becomes available, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 9 atmospheres (atms) while treating the target lesion.The health care professional (hcp) used a contralateral approach through the right common femoral artery to treat the left superficial femoral artery (sfa).The hcp did not predilate the target lesion and it is unknown if the vessel was calcified or tortuous.The hcp prepared the balloon in the normal fashion and removed the balloon protector without issues.The hcp used a cook flexor 6 french introducer sheath over a terumo 035 glidewire to advance the lutonix dcb, under negative pressure, to the target lesion.Reportedly, the lutonix dcb was inflated once and the balloon ruptured while attempting to treat the target lesion.The lutonix dcb was removed and a second lutonix dcb 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 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: 7172344
• Report Number: 3006513822-2017-00312
• Device Sequence Number: 13666371
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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: 06/08/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513061505F
• Device Lot Number: GFBT0665
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 01/22/2018
• 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: 169