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

Model Number	9004
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure through the radial access, allegedly there was a resistance when the drug coated balloon was advanced over the wire.It was further reported that balloon failed to deflate but after several attempts, balloon was punctured with a needle through patients skin and deflated eventually.Reportedly, the physician felt resistance while removing the balloon through the sheath.The procedure was completed using another device.There was no reported patient injury.
Additional 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: 01/2024).
Additional 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 luntonix 035 drug coated balloon loaded with a unknown guidewire and unknown sheath has returned for evaluation.The distal tip of the sheath noted to be buckled.No other specific anomalies noted.The balloon was cut, and bunching was noted the proximal and distal end of the balloon.The catheter was cut, and it was noted an opaque material bunched up within the guidewire lumen.No functional testing performed due to the condition of the device returned for evaluation and the balloon was also punctured by the user facility.All the anomalies noted on the microscopic observation.Therefore, the investigation for the reported deflation issue remains inconclusive as no functional testing performed due to condition of device.The investigation for the reported difficult to advance and device-device incompatibility remains inconclusive as no functional testing performed due to condition of device.However, the investigation was confirmed for the reported difficult to remove as the device returned in a condition like loaded and noted be stuck within the unknown guide wire and unknown sheath.The investigation was also confirmed for the identified material separation as opaque material bunched up within the guidewire lumen, when the catheter cut during the evaluation.During the evaluation of the returned device opaque material was observed within the inner guide wire lumen most likely contributed by advancement of guide wire into the catheter.However definitive root cause for the reported deflation issue, difficult to advance, device-device incompatibility, difficult to remove and identified material separation 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.D4 (expiry date: 01/2024).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 or Problem Description
It was reported that during an angioplasty procedure through the radial access, allegedly there was a resistance when the drug coated balloon was advanced over the wire.It was further reported that balloon failed to deflate but after several attempts, balloon was punctured with a needle through patients skin and deflated eventually.Reportedly, the physician felt resistance while removing the balloon through the sheath.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATATION CATHETER
• Common Device Name: 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: 12809825
• Report Number: 3006513822-2021-00055
• Device Sequence Number: 20211519
• Product Code: ONU
• UDI-Device Identifier: 00801741123313
• UDI-Public: (01)00801741123313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: LX351307405F
• Device Lot Number: GFEZ0229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male