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

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that in preparation for a 12 month follow up visit for a clinical trial, the patient¿s chart had indicated the patient had expired.The patient had undergone an index procedure using a drug-coated balloon catheter in the left upper arm in the cephalic vein at the outflow approximately seven months and eight days before expiration.No information in chart was provided regarding the patient¿s cause of death.The relationship of the adverse event with the device, procedure and av access circuit are unknown.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 10/2021).
Event or Problem Description
It was reported that in preparation for a twelve month follow up visit for a clinical trial, the patient¿s chart had indicated the patient had expired.The patient had undergone an index procedure using a drug-coated balloon catheter in the left upper arm in the cephalic vein at the outflow approximately seven months and eight days before expiration.No information in chart was provided regarding the patient¿s cause of death.The relationship of the adverse event with the device, procedure and av access circuit are unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 10/2021).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.H3 other text: device not returned.
Event or Problem Description
It was reported that in preparation for a twelve month follow up visit for a clinical trial, the patient¿s chart had indicated the patient had expired.The patient had undergone an index procedure using a drug-coated balloon catheter in the left upper arm in the cephalic vein at the outflow approximately seven months and eight days before expiration.No information in chart was provided regarding the patient¿s cause of death.The relationship of the adverse event with the device, procedure and av access circuit are unknown.
Additional Manufacturer Narrative
H10: the previous supplemental mdr was inadvertently submitted with a g3 date of 08/18/2022.The correct g3 date for previous supplemental mdr is 11/23/2022.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.A definitive root cause could not be determined based upon the available 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: d4 (expiration date: 10/2021), g3, h2.H11: g1 (manufacturing location).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.H3 other text : device not returned.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15433712
• Report Number: 3006513822-2022-00029
• Device Sequence Number: 5673168
• Product Code: PRC
• UDI-Device Identifier: 00801741135514
• UDI-Public: (01)00801741135514
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9010
• Device Catalogue Number: LX35751040V
• Device Lot Number: GFDW2404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 08/18/2022; 12/23/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 12/16/2022; 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 135 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White