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 Hypersensitivity/Allergic reaction (1907)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 2 additional pseudoporphyria complaints which are associated with the same patient for this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual samples were not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed that the event was possibly related to the study devices, not related to the procedure and not related to the av access circuit.Based on the instructions for use (ifu), the potential adverse events include allergic reaction to the drug coating or excipients as an inherent risk of any procedure involving drug coated balloons.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.

Event Description

It was reported through a clinical registry that during a index procedure, three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the cephalic vein juxta-anastomotic and outflow track of the av fistula.Approximately 8 months after the index procedure the patient experienced pseudoporphyria.The patient has been referred to dermatology for evaluation and assessment of pseudoporphyria source.The investigator assessed that the event was possibly related to the study devices, not related to the procedure and not related to the av access circuit.The samples were discarded by the user facility and are not available for evaluation.No further adverse patient effects were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2019-00024 and 3006513822-2019-00025.

Event Description

It was reported through a clinical registry that during a index procedure, three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the cephalic vein juxta-anastomotic and outflow track of the av fistula.Approximately 8 months after the index procedure the patient experienced pseudoporphoryia.The patient has been referred to dermatology for evaluation and assessment of pseudoporphryia source.The event description had the following information added, "the dermatologist prescribed diprolene and no further follow up is scheduled with the dermatologist.The investigator assessed that the event was possibly related to the study devices, not related to the procedure and not related to the av access circuit.The samples were discarded by the user facility and are not available for evaluation.No further adverse patient effects were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2019-00024 and 3006513822-2019-00025.

Manufacturer Narrative

Corrected information: event date was changed from "(b)(6) 2018" to "(b)(6) 2018." additional information: the event description had the following information added, "the dermatologist prescribed diprolene and no further follow up is scheduled with the dermatologist." the relevant test and lab data had the following added, "the patient was prescribed a medication, diprolene, and no further follow up with the dermatologist is scheduled." analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 2 additional pseudoporphoryia complaints are associated with the same patient for this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual samples were not returned for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed that the event was possibly related to the study devices, not related to the procedure and not related to the av access circuit.The dermatology evaluation involved a 4-mm skin biopsy for an immunofluorescence study which revealed the pseudoporphoryia was due to bullous pemphigiod rather than a hypersensitivity from a drug eruption of paclitaxel.Based on the instructions for use (ifu), the potential adverse events include allergic reaction to the drug coating or excipients as an inherent risk of any procedure involving drug coated balloons.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.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.

Manufacturer Narrative

Additional information: the relevant test and lab data had the following added, "dermatology evaluation involved a 4-mm skin biopsy for an immunofluorescence study which revealed the pseudoporphoryia was due to a bullous pemphigiod." "213" eval code & desc - result was added.Analysis conclusion added the following, "the dermatology evaluation involved a 4-mm skin biopsy for an immunofluorescence study which revealed the pseudoporphoryia was due to bullous pemphigiod rather than a hypersensitivity from a drug eruption of paclitaxel." analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 2 additional pseudoporphoryia complaints are associated with the same patient for this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual samples were not returned for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed that the event was possibly related to the study devices, not related to the procedure and not related to the av access circuit.The dermatology evaluation involved a 4-mm skin biopsy for an immunofluorescence study which revealed the pseudoporphoryia was due to bullous pemphigiod rather than a hypersensitivity from a drug eruption of paclitaxel.Based on the instructions for use (ifu), the potential adverse events include allergic reaction to the drug coating or excipients as an inherent risk of any procedure involving drug coated balloons.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.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.

Event Description

It was reported through a clinical registry that during a index procedure, three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the cephalic vein juxta-anastomotic and outflow track of the av fistula.Approximately 8 months after the index procedure the patient experienced pseudoporphoryia.The patient has been referred to dermatology for evaluation and assessment of pseudoporphryia source.The investigator assessed that the event was possibly related to the study devices, not related to the procedure and not related to the av access circuit.The samples were discarded by the user facility and are not available for evaluation.No further adverse patient effects were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2019-00024 and 3006513822-2019-00025.

• 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
• MDR Report Key: 8368262
• MDR Text Key: 137131654
• Report Number: 3006513822-2019-00026
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741166136
• UDI-Public: (01)00801741166136
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 9004
• Device Catalogue Number: 9090475500040
• Device Lot Number: GFAZ2192
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 03/19/2019; 03/19/2019
• Supplement Dates FDA Received: 03/27/2019; 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 55