MAUDE Adverse Event Report: LUTONIX, INC 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	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the returned catheter did have striations, wrinkles present in the middle of the balloon material, which is consistent with the balloon material being twisted.However, functional testing of the sample did not reveal any twisting abnormalities during inflation or deflation.A fluoroscopy image from the physician was provided, demonstrating the twisting balloon during inflation at the target lesion.It was reported that the lutonix dcb was prepped per the ifu and the hcp delivered the lutonix dcb over an 0.014 csi viperwire guidewire.The hcp reportedly did not use a twisting motion during advancement, but did use a linear push technique with the lutonix dcb.Under fluoroscopy, while the lutonix dcb was inflated, reportedly a portion of the balloon did not inflate.No additional balloon was used to complete the procedure, since this was the second lutonix dcb used on the patient for this target lesion.No adverse patient outcomes were reported.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 left superficial femoral artery, the drug coated balloon allegedly twisted and was difficult to inflate.No further treatment was needed.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): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9014466
• Report Number: 3006513822-2019-00117
• Device Sequence Number: 2529511
• Product Code: ONU
• UDI-Device Identifier: 00801741177705
• UDI-Public: (01)00801741177705
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 09/12/2019

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: LX1813062205F
• Device Lot Number: GFDQ2535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 90