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

Model Number	9004
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9838386
• Report Number: 3006513822-2020-00006
• Device Sequence Number: 19023900
• Product Code: ONU
• UDI-Device Identifier: 00801741163401
• UDI-Public: (01)00801741163401
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 58