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

Model Number 9004

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The device history records are currently under review.The return of the device is pending.The company is still investigating the issue at this time.Upon receipt of the new or additional information, a follow-up report will be submitted as applicable.(expiry date: 03/2020).

Event Description

It was reported that prior to an angioplasty procedure, the labeling of the inner packaging pouch did not match the labeling of the outer packaging box.It was further reported that the sticker containing product information was not present on the inner packaging pouch.Another device was used to perform the procedure.There was no reported patient contact.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the packaging sample was returned by the facility for further evaluation.The returned items from this customer do have different lot numbers on the labels of the carton and the pouch.It cannot be clearly determined the returned pouch was originally inside the allegedly sealed carton prior to opening the carton as the customer reports.A review of the manufacturing records from the two lots (gfbr2297 [carton] and gfbr0295 [pouch]) that these two lots were created at different time periods.Lot gfbr2297 was the child lot of gfbq1700 and was labeled at glen falls operations, new york, usa.Lot gfbr0295 was the over labeled lot from gfsa0886 and this over labeling operation was performed at a facility in sydney, australia.It was further identified that the reporting customer facility was sent items from both lot numbers which are alleged to be mismatched.The customer facility was shipped two items from lot # gfbr0295, one was received in april 2017 and the other was received in july 2017.The customer facility was shipped one item from lot # gfbr2297, which was received in feb 2018.Labeling review: labeling review is not applicable for this allegation as it is a labeling issue.H10: d4: (expiry date: 03/2020).H11: h6 (results1, conclusion1).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 Description

It was reported that upon opening the sealed package, the labeling of the inner packaging pouch did not match the labeling of the outer packaging box.It was further reported that the sticker containing product information was not present on the inner packaging pouch.Another device was used to perform the procedure.There was no reported patient contact.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9440112
• MDR Text Key: 208573823
• Report Number: 3006513822-2019-00136
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741200199
• UDI-Public: (01)00801741200199
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

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: 9040413500120
• Device Lot Number: GFBR2297
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1