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

Model Number	9004
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: DRUG COATED BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9235607
• Report Number: 3006513822-2019-00130
• Device Sequence Number: 398807
• Product Code: ONU
• UDI-Device Identifier: 00801741123290
• UDI-Public: (01)00801741123290
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 61