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

Model Number	9010
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2023).The information provide by bd represents all the known information at this time.
Event or Problem Description
It was reported that prior to the procedure, the package allegedly damaged.It was further reported that sterile barrier allegedly breached.The product allegedly contaminated.There was no patient contact.
Event or Problem Description
It was reported that prior to the procedure the package was allegedly damaged.It was further reported that the device was allegedly unsterile.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned, 3 electronic photos were provided for review.Photo 1 shows a portion of a lutonix 035 outer packaging box.The corner of the box appears to be damaged, appearing crushed and beginning to rip.The outer box seal appears to be intact.The device and inner packaging cannot be visualized in the photo.Photo 2 shows a the product labeling with the lot number and catalog number matching the reported information.Photo 3 shows the outer packaging box appearing to be bulged.The top corner of the box can be seen to be damaged.Based on the photo review, the damaging to the outer packaging can be confirmed.However, the reported sterility issues remains inconclusive, as the condition of the inner sterile barrier cannot be seen in the provided photos.Per the reported event details, the sterility was not confirmed as breached.However, the definitive root cause for the identified packaging issue and sterility issue could not be determined.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.H3 other text : device not returned.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATION 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: 11676700
• Report Number: 3006513822-2021-00013
• Device Sequence Number: 16918305
• Product Code: PRC
• UDI-Device Identifier: 00801741135392
• UDI-Public: (01)00801741135392
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 9010
• Device Catalogue Number: LX3575660V
• Device Lot Number: GFEW1672
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 06/01/2021
• 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