MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 018 DRUG COATED BALLOON CATHETER; DRUG COATED PTA BALLOON CATHETER

Model Number	9014
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned from the user facility; therefore, device evaluations are unable to be performed.Lot history review revealed this is the only complaint reported for lot gfdq2534.The device history record was reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the catheter was not returned for evaluation, however, a fluoroscopy image was provided during the procedure.It was reported the calcific target lesion was prepared with atherectomy prior to the hcp delivering the lutonix dcb over an 0.014 viper guidewire through a 6 french introducer sheath.The hcp reported the twisting was evident, when the indeflator was increased to 2 atmospheres and remained twisted while the lesion was treated for 3 minutes at 7 atmospheres.A fluoroscopy, while the lutonix dcb was inflated, was provided demonstrating a portion of the balloon did not inflate uniformly.The physician used a second to complete the procedure.The root cause could not be determined based upon the available information received from the field communications.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during an angioplasty procedure in the right superficial femoral artery, the drug coated balloon allegedly twisted.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LUTONIX 018 DRUG COATED BALLOON CATHETER
• Common Device Name: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8893918
• Report Number: 3006513822-2019-00106
• Device Sequence Number: 259569
• Product Code: ONU
• UDI-Device Identifier: 00801741177620
• UDI-Public: (01)00801741177620
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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: 02/21/2021
• Device Model Number: 9014
• Device Catalogue Number: LX1813051505F
• Device Lot Number: GFDQ2534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 89