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

Model Number 9004

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one lutonix 035 device has returned for evaluation.No guidewire or insertion sheath were returned.On the visual evaluation of the device, the device appeared bloody and no specific anomalies were noted.On the functional evaluation of the device, an attempt was made to flush the guidewire lumen, but water was noted exiting from the inflation luer.And another attempt was also made to inflate balloon but water was also noted to be exiting from the guidewire luer.During these two attempts air bubbles were noted within the y-body and connection luers.Further the catheter was removed by cutting the y-body and under microscopic examination a compound and longitudinal tear was noted to the inner guidewire lumen.No other functional testing was performed.Therefore the investigation is confirmed for the identified leak as the water was noted exiting from the inflation luer and the guidewire luer.The investigation is also confirmed for the identified inner guidewire lumen tear as the compound and longitudinal tear was noted to the inner guidewire lumen during the microscopic observation.A definitive root cause for the alleged identified leak and identified inner guidewire lumen tear could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.

Event Description

It was reported that prior to an angioplasty procedure, the device was allegedly defective.The procedure was completed by using another device.There was no patient contact.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATATION CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12771024
• MDR Text Key: 281918826
• Report Number: 3006513822-2021-00053
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741166952
• UDI-Public: (01)00801741166952
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: 9090413600150
• Device Lot Number: GFCX0346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1