MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 018 DRUG COATED BALLOON CATHETER; DRUG COATED PTA BALLOON CATHETER

Model Number	9014
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image is provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2023).
Event or Problem Description
It was reported during an angioplasty procedure, the drug coated balloon allegedly twisted during inflation.It was further reported that, the balloon was deflated and inflated for the second time.The procedure was completed using same device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation, however, one medical image was provided and reviewed.A waist in the balloon was noted just beyond the midpoint during inflation.Based on the image review, the material twisting during inflation can be confirmed.The definitive root cause for the reported balloon twisting during inflation could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.D4(expiry date: 04/2023).H11: section a through f - 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.H3 other text : device not returned.
Event or Problem Description
It was reported during an angioplasty procedure through right groin access via contralateral approach, the drug coated balloon allegedly twisted during inflation.It was further reported that the balloon was deflated and inflated for the second time.The procedure was completed using same device.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 55428
• MDR Report Key: 10873529
• Report Number: 3006513822-2020-20006
• Device Sequence Number: 2828697
• Product Code: ONU
• UDI-Device Identifier: 00801741177620
• UDI-Public: (01)00801741177620
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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 Model Number: 9014
• Device Catalogue Number: LX1813051505F
• Device Lot Number: GFET1513
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other