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

Model Number 9004

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.(expiry date: 11/2020).

Event Description

It was reported that during an angioplasty procedure in the superficial femoral artery, the balloon allegedly ruptured.It was further reported that the balloon had difficulty retracting through the sheath, and there was detached device material within the sheath.The device was successfully removed, and the detached material was removed with the sheath.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the superficial femoral artery, the device allegedly tore into two pieces.It was further reported that the balloon had difficulty retracting through the sheath and the health care provider had to pull hard on the device to remove it from the sheath.Reportedly, there was detached device material within the sheath and on the guidewire.The device was successfully removed and the detached material was removed with the sheath and the guidewire.There was no reported patient injury.

Manufacturer Narrative

H10: new information was received that changed the interpretation of the event as initially reported by the complainant.As such, the event description and device codes have been updated.Lot history review revealed this is the only complaint for this lot number.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The returned sample analysis confirms the events reported by the hcp did occur, and the excessive force reported by the hcp likely resulted in the separation of the balloon from the main shaft.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: g4, h4 (manufacturing date: 01/2019), h6 (method: 3331 - analysis of product records) h11: b5, h3, h6 (device code, method, results, conclusion).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.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9838386
• MDR Text Key: 215145913
• Report Number: 3006513822-2020-00006
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741163401
• UDI-Public: (01)00801741163401
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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 Expiration Date: 11/28/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513042205F
• Device Lot Number: GFDR0566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/10/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 58