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

Model Number 9004

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis: the sample has been returned to the manufacturer; therefore, evaluation is anticipated but has not yet begun.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.A reviewed of the manufacturing record showed the lot was manufactured to specification.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: the actual sample has been received, but the evaluation has not been completed.The dhr found nothing to indicate a manufacturing related cause for this event.Upon completion of the investigation, a supplement 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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was difficult to remove from the guidewire.The health care professional (hcp) used an 035 guidewire to gain access to the target lesion.The hcp successfully loaded the catheter onto the guidewire and maneuvered it to the target lesion.Reportedly, the hcp inflated the balloon to perform a successful treatment.Allegedly, the hcp had difficulty pulling the catheter out of the patient as it was stuck on the guidewire.The outer shaft of the catheter reportedly separated from the inner shaft of the catheter.Although requested, further event details have not been obtained from the user facility.The lutonix dcb has been requested to be returned for evaluation.No adverse patient effects were reported.

Manufacturer Narrative

Added information below.(b)(4).Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter.The sample was returned with a guidewire stuck in the inner lumen.The outer shaft was separated from the inner lumen at the balloon's proximal bond.The catheter hub was attached only to the outer shaft.The inner lumen was bulged and curved.The outer shaft was kinked throughout the entire catheter, between the following geomarkers 36-37, near 49 and 63, between 95 and 96.Under magnification, the inner lumen was severely accordioned inside the balloon and the proximal marker band was displaced towards the distal portion of the catheter, due to the inner lumen being accordioned.The inner lumen was also overlapped at several places throughout the catheter.Functional testing was attempted by the investigator by applying traction at the distal tip to remove the guidewire, but the guidewire would not move.The guidewire coils, near the distal tip of the balloon, appeared to be stretched and covered with residual blood.Since the guidewire was stuck inside the inner lumen, due to inner lumen being accordioned, destructive testing was performed in an attempt to remove the guidewire.The guidewire and the coil filars were found to be covered with heavy residual blood along the guidewire.The guidewire was slightly bent in one area, which may have possibly caused the guidewire to become stuck.A lot history review revealed this is the only complaint associated with this lot.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis confirmed the lutonix dcb dilatation catheter allegedly was difficult to remove from the guidewire.During attempts by the hcp to remove the catheter over the guidewire, the catheter was severely damaged and the outer shaft was separated from inner lumen with the guidewire stuck in the inner lumen, which was likely due to excessive force applied while trying to remove the catheter.Also, the heavy residual blood on the guidewire may have contributed to the entrapment of guidewire in the inner lumen.It is unknown if the hcp applied negative pressure during advancement and during removal of the catheter.It is also unknown if the pathway and/or the lesion were calcified/torturous.The dhr found nothing to indicate a manufacturing related cause for this event.If additional event information is obtained, a supplement 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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was difficult to remove from the guidewire.The health care professional (hcp) used an 035 guidewire to gain access to the target lesion.The hcp successfully loaded the catheter onto the guidewire and maneuvered it to the target lesion.Reportedly, the hcp inflated the balloon to perform a successful treatment.Allegedly, the hcp had difficulty pulling the catheter out of the patient as it was stuck on the guidewire.The outer shaft of the catheter reportedly separated from the inner shaft of the catheter.Although requested, further event details have not been obtained from the user facility.The lutonix dcb has been requested to be returned for evaluation.No adverse patient effects were reported.

• 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: 6491002
• MDR Text Key: 72810169
• Report Number: 3006513822-2017-00062
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088544
• UDI-Public: (01)00801741088544(17)180131(10)GFAT0224
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 9004
• Device Catalogue Number: 9080413400040
• Device Lot Number: GFAT0224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• 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