MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035AV; DRUG COATED PTA DILATION CATHETER

Model Number	9010
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, balloon allegedly had a deflation problem.It was further reported that the catheter was allegedly removed.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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 03/2023).Device pending return.
Additional Manufacturer Narrative
H10: 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 partially detached lutonix 035av drug-coated balloon catheter was returned for evaluation.No other anomalies were noted during the visual evaluation.Functional testing was not performed due to the condition of the device.However, the investigation remains inconclusive for the reported deflation issue as the functional testing couldn¿t be performed due to the condition of the device.A definitive root cause for the reported deflation issue 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.H10: d4 (expiry date: 03/2023), g3.H11: b5, h6 (method, result, 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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the drug-coated balloon allegedly failed to deflate.It was further reported that the balloon was deflated using a needle.Reportedly, the catheter was cut and it was pulled back into the sheath.The device was removed from the patient.There was no reported patient injury.

• Brand Name: LUTONIX 035AV
• Common Device Name: DRUG COATED PTA DILATION CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15507683
• Report Number: 3006513822-2022-00033
• Device Sequence Number: 12218611
• Product Code: PRC
• UDI-Device Identifier: 00801741135521
• UDI-Public: (01)00801741135521
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• 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): 11/02/2022

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: 9010
• Device Catalogue Number: LX35751060V
• Device Lot Number: GFGN1819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/14/2022
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 96 KG