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

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned from the user facility; therefore, device evaluations are unable to be performed.Lot history review revealed this is the only complaint reported for lot: gfcr3699.The device history record was reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was discarded from the user facility.It is known that the patient had several different allergies noted on their chart.The patient was exposed to heparin, tpa, contrast, and paclitaxel during the angioplasty procedure.The patient experienced anaphylaxis symptoms 5 minutes post procedure.The patient experienced hives all over the body and a swollen airway , which caused difficulty in breathing.The patient was brought to the icu and the patient was stabilized by intubation and monitoring.The patient's symptoms resolved overnight.The root cause could not be determined based upon the available information received from the filed communications.Labeling review: ifu dw5159-01 in section 8 states potential adverse events which may be associated with a peripheral balloon dilatation procedure includes: allergic reaction to drugs, excipients or contrast medium as well as shock.In section 9.0 physician counseling information states physicians should consider the following in counseling patients about this product: discuss the risks associated with a pta procedure.Discuss the risks associated with a paclitaxel coated pta catheter.Discuss the risks/benefits issues.
Event or Problem Description
It was reported that upon completion of an angioplasty procedure in a forearm fistula, the patient allegedly developed an anaphylactic reaction.The health care provided reportedly believes that paclitaxel is one of the "most likely" causes of the possible anaphylactic reaction.The patient was transported to the intensive care unit, where the reaction was resolved overnight.The patient was reportedly stable after the reaction was resolved.
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned from the user facility; therefore, device evaluation was unable to be performed.Lot history review revealed this is the only complaint reported for lot gfcr3699.The device history record was reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was discarded from the user facility.It is known the patient had several different allergies, but these were not provide to bd for investigation.During the angioplasty procedure, the patient was exposed to heparin, tpa, contrast, and paclitaxel.Approximately 5 minutes post procedure the patient experienced anaphylaxis, involving hives all over the body and a swollen airway causing difficulty breathing.A code blue was called to assist the distressed patient.After stabilizing the patient, through intubation, they were brought to the icu for further monitoring.The patient's symptoms resolved within 24 hours.The interventional radiologist who performed the fistuloplasty believes the "most likely" cause of the adverse event was due to paclitaxel, after confirming the patient did not have an adverse reaction to heparin or tpa in past medical procedures.The root cause could not be determined based upon the available information received from the filed communications.Labeling review: ifu (b)(4) in section 8 states potential adverse events which may be associated with a peripheral balloon dilatation procedure includes: allergic reaction to drugs, excipients or contrast medium as well as shock.In section 9.0 physician counseling information states physicians should consider the following in counseling patients about this product: discuss the risks associated with a pta procedure.Discuss the risks associated with a paclitaxel coated pta catheter.Discuss the risks/benefits issues.
Event or Problem Description
It was reported that upon completion of an angioplasty procedure in a forearm fistula, the patient allegedly developed an anaphylactic reaction.The health care provided reportedly believes that paclitaxel is one of the "most likely" causes of the possible anaphylactic reaction.The patient was transported to the intensive care unit, where the reaction was resolved overnight.The patient was reportedly stable after the reaction was resolved.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATATION CATHETER
• Common Device Name: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8933075
• Report Number: 3006513822-2019-00111
• Device Sequence Number: 13964980
• Product Code: PRC
• UDI-Device Identifier: 00801741135392
• UDI-Public: (01)00801741135392
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2021
• Device Model Number: 9010
• Device Catalogue Number: LX3575660V
• Device Lot Number: GFCR3699
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other