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

Model Number 9004

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2022).

Event Description

It was reported during an angioplasty procedure, the doctor could not see the markers under fluoroscopy.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: based on the investigation findings, the reported device dislodged issue is unconfirmed and the file is no longer reportable.Since an initial mdr has been submitted to fda, the reportability of the file will remain same.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:the sample was returned to the manufacturer for evaluation.The returned sample analysis confirmed the marker bands were present and located at the appropriate locations.Both marker bands were radiopaque through an x-ray evaluation.The investigation is unconfirmed for the reported issue.The root cause of the lack of marker band visibility complaint could not be determined based upon the available information received from field communications and the returned sample analysis.Labeling review: instructions for use device description, 1:1 pta catheter description: two radiopaque marker bands delineate the working length of the balloon and are located under the proximal and distal ends of the balloon to facilitate fluoroscopic visualization of the balloon during delivery and placement.Geoalign¿ marker bands are designated on the catheter shaft by 1 cm increment bands.Geoalign¿ marker bands are designed to be used as a location reference tool.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 Description

It was reported during an angioplasty procedure, the doctor could not see the markers under fluoroscopy.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATATION CATHETER
• Type of Device: DRUG COATED PTA DILATATION CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 10418790
• MDR Text Key: 203326154
• Report Number: 3006513822-2020-00026
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741166945
• UDI-Public: (01)00801741166945
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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
• Device Operator: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: 9090413600120
• Device Lot Number: GFCZ2412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR