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	Material Rupture (1546); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that prior to the angioplasty procedure, the balloon was allegedly had a hole when it was opened.There was no patient contact.
Event or Problem Description
It was reported that prior to the angioplasty procedure, the balloon was allegedly had a hole when it was opened.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one lutonix pta balloon dilation catheter was returned for evaluation.On visual evaluation, it was noted there were tears to the catheter shaft and also the balloon was ruptured at multiple sites.On microscopic observations, it appeared like tears on the shaft of catheter.On functional evaluation, in-house presto inflation device was used to inflate the balloon and water was noted to leaking form the catheter shaft.Therefore, the investigation for the reported material rupture is confirmed as the balloon has multiple tears noted on the device which returned for evaluation.Therefore, the investigation for the reported device damaged prior to use is confirmed as the returned device contain multiple tears on the catheter shaft noted under microscopic observation and water leaks during the functional evaluation.A definitive root cause for the alleged device damaged prior to use and material rupture 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: g3, h6 (method) h11: h6 (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.See h10.

• 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 MN 55428
• MDR Report Key: 12278997
• Report Number: 3006513822-2021-00039
• Device Sequence Number: 16865309
• Product Code: ONU
• UDI-Device Identifier: 00801741126888
• UDI-Public: (01)00801741126888
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/19/2021

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: LX351306805F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other