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

Model Number 9004

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

It was reported that prior to an angioplasty procedure, the device packaging was allegedly not sealed completely.After noticing the alleged incomplete seal, the package was opened all the way in preparation for the procedure.After the physician was alerted to the alleged issue, the physician elected to not use the device and reportedly used another device to complete the procedure.It was further reported that the outer box and the tamper proof seal were not damaged.There was no reported patient contact.

Event Description

It was reported that prior to an angioplasty procedure, the device packaging was allegedly not sealed completely.After noticing the alleged incomplete seal, the package was opened all the way in preparation for the procedure.After the physician was alerted to the alleged issue, the physician elected to not use the device and reportedly used another device to complete the procedure.It was further reported that the outer box and the tamper proof seal were not damaged.There was no reported patient contact.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.There was nothing found to indicate there was a manufacturing related cause for this event.The device has been returned to the manufacturer for evaluation.The investigation of the reported malfunction unconfirmed a breach of sterile barrier.The inner side of the seal on the pouch was examined for deformities in the seal such as channels, creases, nicks, or pinholes, and the seal was found to have no defects.The seal width was continuous, which indicates the sealing process was properly completed during manufacturing.The evidence suggests the sterile barrier was intact, until the inner pouch was opened by a user.Therefore, the evaluation unconfirmed the alleged report that the device's inner pouch was not sealed.The device is labeled for single use.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.

• 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: 9235607
• MDR Text Key: 192159331
• Report Number: 3006513822-2019-00130
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741123290
• UDI-Public: (01)00801741123290
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

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: Other
• Device Expiration Date: 09/12/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513061205F
• Device Lot Number: GFBW0388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 61