MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number 9004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Analysis: the samples were not returned; therefore, evaluation was not able to be performed.A lot history review and a device history record (dhr) review could not be conducted because product identifiers were unavailable.In reviewing the labeling supplied with this product, it was found that the instructions for use (ifu) sufficiently address these potential factors.The ifu states ¿potential adverse events that may be unique to the lutonix catheter paclitaxel drug coating include: allergic reaction to drug coating.There may be other potential adverse events that are unforeseen at this time.¿ conclusion: the actual samples were not received for evaluation.Although requested, a lot history review and a device history record (dhr) review could not be conducted because product identifiers were unavailable.The investigation was limited to the literature article and the follow up information obtained through field inquires.It is unknown if patient physiology or an adverse reaction(s) with other devices/medications from the procedure could have contributed to the event.The patient was treated with a topical ointment and oral steroids, then released from the hospital.A review of our quality database noted one additional event occur from the same hospital and operating physician.Lutonix continues to monitor the field performance of this device to detect similar events, should they occur.If additional information is obtained from the field, a supplemental report will be submitted with all relevant information.The information provided by bard 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 bard.

Event Description

It was reported through the journal "jaad case reports, volume 4, number 1", two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters allegedly resulted in cutaneous polyarteritis nodosa of the left leg.The patient developed cutaneous polyarteritis nodosa, or rash, in approximately 4 weeks after the index procedure.As a result, the patient was hospitalized and diagnostic testing was performed involving a punch biopsy of a nodule.The health care professional (hcp) examined the patient, who presented with painful erythematous nodules extending from the left ankle to the mid thigh.Necrosis, ulcers, and livedo reticularis were not present.Sensory and motor examinations were unremarkable, with no signs of neuropathy.The patient was treated with topical ointment and oral prednisone, then released from the hospital.Although requested, no additional information has been obtained from the author of the case report.It is unknown if additional adverse patient effects were reported.The lutonix dcb was discarded by the user facility and not available for return.This is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2018-00014.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: john risse ; 9409 science center dr; new hope, MN 55428 ; 7634632917
• MDR Report Key: 7226198
• MDR Text Key: 98494052
• Report Number: 3006513822-2018-00013
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: UNK SFA 035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR