MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2022).
Event or Problem Description
It was reported during an angioplasty procedure, the device balloon allegedly twisted and failed to inflate.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported during an angioplasty procedure, the device balloon allegedly twisted and failed to inflate.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one device was returned for evaluation.The device was noted to have twisting and striations to the balloon portion.Negative pressure was pulled on the balloon and the balloon was able to deflate without issues.The guidewire lumen was flushed and the guidewire was inserted through the device without issues.The balloon was then inflated to nominal pressure and the balloon was noted to maintain uniform shape and pressure.The balloon was then deflated without issues, however twisting was still present at the balloon site.Therefore, the investigation is confirmed for the reported twisted material, as the device was returned with material twisting to the balloon portion.The investigation is unconfirmed for the reported inflation issue, as the device was able to be inflated and deflated without issues while maintaining uniform shape and pressure.However, the definitive root cause for the reported material twisting and inflation issue 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.H10: d4 (expiry date: 02/2022).H11: section a through f ¿ the information provide by bd represents all 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.

• Brand Name: LUTONIX 018 DRUG COATED DILATATION CATHETER
• Common Device Name: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope 55428
• MDR Report Key: 10939659
• Report Number: 3006513822-2020-20007
• Device Sequence Number: 10938372
• Product Code: ONU
• UDI-Device Identifier: 00801741184727
• UDI-Public: (01)00801741184727
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/30/2021

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: LX1813063005F
• Device Lot Number: GFEN3643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 04/21/2021
• 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