MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Codes	Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
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: 04/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the drug coated balloon allegedly failed to thread over the guidewire.It was further reported that guidewire was stiff and white residue/fibers coming out the end of the balloon and covering wire.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: (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.
Event or Problem Description
It was reported that during an angioplasty procedure, the drug coated balloon allegedly failed to thread over the guidewire.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATATION CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope 55428
• MDR Report Key: 11723798
• Report Number: 3006513822-2021-00020
• Device Sequence Number: 3946166
• Product Code: ONU
• UDI-Device Identifier: 00801741123320
• UDI-Public: (01)00801741123320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 9004
• Device Catalogue Number: LX351307605F
• Device Lot Number: GFEQ3695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/31/2021
• 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