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

Model Number	9010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/preliminary evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed a longitudinal material rupture extending from the proximal balloon bond to the middle of the balloon.Functional testing of the complaint sample concluded the longitudinal material rupture would not allow the balloon to inflate.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 review of the device history record (dhr) indicates the lot was manufactured to specification.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.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating a non calcified target lesion located in the av fistula.The health care professional (hcp) gained access from the patient's arm with a 7 french boston scientific super sheath over an 035 bentson guidewire.Reportedly, the hcp predilated the target lesion with a 8 x 60mm mustang percutaneous transluminal angioplasty (pta) balloon.The hcp reached the target lesion with the lutonix dcb and attempted to inflate the balloon.Reportedly, on the first inflation the lutonix dcb allegedly ruptured after achieving 8 atmospheres (atms) of pressure.The procedure was completed with an additional lutonix dcb.The lutonix dcb was returned for evaluation.No adverse patient outcomes were reported.
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter.Under magnification, a longitudinal material rupture was present, starting from the proximal balloon cone extending past the middle of the balloon.The edges of the material rupture were smooth.There appears to be light surface scratches around the j-shaped termination of the material rupture on the balloons proximal cone.Functional testing of the complaint sample concluded the longitudinal material rupture would not allow the balloon to inflate.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: returned product analysis confirmed a longitudinal material rupture was present, starting from the proximal balloon cone extending past the middle of the balloon.The edges of the material rupture were smooth.There appears to be light surface scratches around the j-shaped termination of the material rupture on the balloons proximal cone.Although requested, additional event details were unavailable.The dhr found nothing to indicate a manufacturing related cause for this event.A definitive root cause could not be determined based on the information provided.It is unknown if the patient and/or procedural issues contributed to the reported event.If additional relevant information becomes available, a supplement report will be submitted 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 or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating a non calcified target lesion located in the av fistula.The health care professional (hcp) gained access from the patient's arm with a 7 french boston scientific super sheath over an 035 bentson guidewire.Reportedly, the hcp predilated the target lesion with a 8 x 60mm mustang percutaneous transluminal angioplasty (pta) balloon.The hcp reached the target lesion with the lutonix dcb and attempted to inflate the balloon.Reportedly on the first inflation, the lutonix dcb allegedly ruptured after achieving 8 atmospheres (atms) of pressure.The procedure was completed with an additional lutonix dcb.The lutonix dcb was returned for evaluation.No adverse patient outcomes were reported.

• Brand Name: LUTONIX 035AV 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: 8156176
• Report Number: 3006513822-2018-00285
• Device Sequence Number: 1625470
• Product Code: PRC
• UDI-Device Identifier: 00801741135712
• UDI-Public: (01)00801741135712
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• 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): 01/10/2019

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: 03/21/2020
• Device Model Number: 9010
• Device Catalogue Number: LX35100860V
• Device Lot Number: GFCQ2569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR