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

Model Number	9004
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, a visual examination over the entire length of the catheter revealed no damage was present.Preliminary functional testing of the catheter demonstrated an 035 guidewire was able to be passed completely through the inner lumen of the catheter and removed without difficulty.The complaint sample was decontaminated and prepared for further evaluation.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: the returned sample is undergoing evaluation which has not yet been completed.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 or Problem Description
It was reported, after treatment, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat a vessel dissection.The health care professional (hcp) used an antegrade approach with a cook amplatz 035 guidewire to gain patient access.The patient was treated with two balloons.Both lutonix dcb's were used, without issues, to treat the target lesion.After the second balloon was inflated, the hcp noted a small dissection and reinserted the second lutonix dcb to post dilate the dissected region.The post dilation was successful.During the removal of the dcb, after the treatment of the dissection, the hcp experienced difficulty removing the guidewire.Upon removal of the guidewire and catheter, the hcp noted kinks in the guidewire, which may have contributed to the removal difficulty.It is unknown if negative pressure was applied during catheter removal.The lutonix dcb was requested to be returned for further evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
Analysis: the evaluation could not confirm the reported event that hcp experienced difficulty removing the guidewire, after the treatment of the dissection.It is unknown if negative pressure was applied during catheter removal.During evaluation, the guidewire was able to be advanced completely through the catheter and removed without any resistance.The dcb was able to be inflated and deflated.No adverse patient effects were reported.(b)(4).Analysis/device evaluation: upon receipt of the sample, a visual examination over the entire length of the catheter revealed no damage was present.Preliminary functional testing of the catheter demonstrated an 035 guidewire was able to be passed completely through the inner lumen of the catheter and removed without difficulty.The complaint sample was decontaminated and prepared for further evaluation.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: the sample was returned and the device analysis was completed.The sample analysis could not confirm the reported allegation regarding the hcp experiencing difficulty while removing the guidewire from the inner lumen of the catheter, after post dilation treatment of the alleged dissection.It is unknown if negative pressure was applied during catheter removal.During evaluation, the guidewire was able to be advanced completely through the catheter and removed without any resistance.The dcb was able to be inflated and deflated.Based on the instructions for use (ifu), the occurrence of a dissection is an inherent risk of any pta procedure.The dhr found nothing to indicate a manufacturing related cause for this event.If additional information becomes available, a supplemental report with all relevant information will be submitted.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 or Problem Description
It was reported, after treatment, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat a vessel dissection.The health care professional (hcp) used an antegrade approach with a cook amplatz 035 guidewire to gain patient access.The patient was treated with two balloons.Both lutonix dcb's were used, without issues, to treat the target lesion.After the second balloon was inflated, the hcp noted a small dissection and reinserted the second lutonix dcb to post dilate the dissected region.The post dilation was successful.During the removal of the dcb, after the treatment of the dissection, the hcp experienced difficulty removing the guidewire.Upon removal of the guidewire and catheter, the hcp noted kinks in the guidewire, which may have contributed to the removal difficulty.It is unknown if negative pressure was applied during catheter removal.The lutonix dcb was requested to be returned for further evaluation.No adverse patient effects were reported.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 5761682
• Report Number: 3006513822-2016-00136
• Device Sequence Number: 16144048
• Product Code: ONU
• UDI-Device Identifier: 00801741088285
• UDI-Public: (01)00801741088285(17)180130(10)GFAN2760
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2016

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 Expiration Date: 01/30/2018
• Device Model Number: 9004
• Device Catalogue Number: 9020410600040
• Device Lot Number: GFAN2760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 08/18/2016
• 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: Required Intervention