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

Model Number 9004

Device Problems Deflation Problem (1149); Retraction Problem (1536); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported during an angioplasty procedure, the drug coated balloon allegedly had a deflation issue.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation.The device was noted to have blood residue throughout the device.The inner guidewire lumen was noted to have stretching.The device as flushed and blood was noted to exit from the distal tip.An in house guidewire was attempted to be inserted through the device but was unsuccessful.Negative pressure was pulled on the device, and the it was unsuccessfully attempted to be inserted into a sheath as resistance was noted during insertion.The balloon was then inflated to nominal pressure, noted to hold uniform shape and deflated without any issues.The inner guidewire lumen was noted to be stretched during inflation.The balloon was cut at the balloon section, and the guidewire able to be passed through the proximal end but not through the balloon section.Therefore, the investigation is confirmed for the reported device incompatibility, as the guidewire would not pass through the device.The investigation is also confirmed for the retraction issue, as the device was noted to have difficulty being inserted into the sheath.The investigation is unconfirmed for the reported deflation issue, as the device was able to be inflated and deflated without any issues.The stretching noted to the inner guidewire lumen is the likely cause of the device incompatibility.However, the definitive root cause for the reported deflation issue, retraction issue and device incompatibility 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.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.

Event Description

It was reported during an angioplasty procedure, the drug coated balloon allegedly had a deflation issue.There was no reported patient injury.

• 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 55428
• MDR Report Key: 11044964
• MDR Text Key: 223171677
• Report Number: 3006513822-2020-20013
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: LX351305150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other