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

Model Number	9004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/preliminary evaluation: upon receipt of the sample, pre-decontamination testing of the complaint sample revealed a material rupture in the distal third of the balloon.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.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 or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured between 2-3 atmospheres (atms)while attempting to treat the target lesion in the superficial femoral artery (sfa).The health care professional (hcp) gained patient access through an ipslateral approach with a 6 french cook rabi introducer sheath.The target lesion was prepared through atherectomy prior to the use of the lutonix dcb.Once the hcp reached the target lesion, the balloon was reportedly inflated and ruptured prior to reaching nominal pressure.Reportedly, the tracking pathway to the target lesion was not tortuous and no previously placed stents were present.The hcp successfully removed the lutonix dcb and completed the patient's procedure with a non drug coated balloon.In the opinion of the hcp, the anatomy was not related to the nature of the material rupture.The lutonix dcb was requested to be returned for evaluation.No adverse patient outcomes were reported.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured between 2-3 atmospheres (atms)while attempting to treat the target lesion in the superficial femoral artery (sfa).The health care professional (hcp) gained patient access through an ipslateral approach with a 6 french cook rabi introducer sheath.The target lesion was prepared through atherectomy prior to the use of the lutonix dcb.Once the hcp reached the target lesion, the balloon was reportedly inflated and ruptured prior to reaching nominal pressure.Reportedly, the tracking pathway to the target lesion was not tortuous and no previously placed stents were present.The hcp successfully removed the lutonix dcb and completed the patient's procedure with a non drug coated balloon.In the opinion of the hcp, the anatomy was not related to the nature of the material rupture.The lutonix dcb was returned for evaluation.No adverse patient outcomes were reported.
Additional Manufacturer Narrative
Additional information: a.2 the patient's age is 85 years old.A.3.The patient gender is female.B.5.The event description has changed due to the sample being returned.G.4.The data the sample investigation was completed was(b)(6)2018 which was added.H.6.Eval code & desc - method codes were added (10, 4111) eval code & desc - results code was removed since the investigation has been completed.Eval code & desc - conclusion codes were changed from "11" to "4310".H3 analysis/device evaluation: upon receipt of the sample, visual examination of the entire length of the catheter which revealed a material rupture was present in the distal to middle area of the balloon.Under magnification, the material rupture was longitudinal in nature and appeared to be crescent shape.Scratches were also present surrounding the surface of the ruptured area.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 material rupture to be a crescent shaped longitudinal rupture with scratches surrounding the rupture area.The hcp prepared the target lesion with atherectomy, but reportedly, the hcp did not predilate the target lesion after the atherectomy.The dhr found nothing to indicate a manufacturing related cause for this event.Thus, a definitive root cause could not be determined based upon the available information.If additional information is received, a supplement report will be submitted with all relevant information.H11:section a through f - 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.

• 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: 7675931
• Report Number: 3006513822-2018-00161
• Device Sequence Number: 848767
• Product Code: ONU
• UDI-Device Identifier: 00801741123283
• UDI-Public: (01)00801741123283
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513061005F
• Device Lot Number: GFCN1534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR