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	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/preliminary evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter which revealed the proximal end of the balloon was slightly wrinkled.Functional testing of the balloon portion of the catheter was performed, which identified a material rupture in the proximal area of the balloon.The sample was decontaminated for further evaluation.A lot history review revealed this is the only complaint associated with balloon rupture for 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 two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters allegedly ruptured longitudinally before reaching nominal pressure while treating the same target lesion.The health care professional (hcp) used a contralateral approach to treat a calcified target lesion in the superficial femoral artery (sfa).The hcp predilated the calcified target lesion with a 4mm non-dcb balloon.The hcp attempted to inflate the first lutonix dcb to treat the calcified target lesion, but it ruptured before reaching nominal pressure.The hcp then took another lutonix dcb, without any additional predilation of the target lesion, and advanced it to the target lesion.The hcp attempted to inflate the second lutonix dcb to treat the calcified target lesion, but it also ruptured prior to reaching nominal pressure.Both balloons were removed without difficultly.In the hcp opinion, the patient's anatomy and calcific nature of the lesion possibly caused the both material rupture on each lutonix dcb.The lutonix dcb's were returned for evaluation.No adverse patient outcomes were reported.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00127.
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter, which revealed the proximal end of the balloon was slightly wrinkled.Functional testing of the balloon portion of the catheter was performed by inflating the balloon to 8 atms, but the balloon was unable to maintain pressure at 8 atms, due to a leak in the proximal area of the balloon.The balloon was examined under the microscope at 20-30x and a longitudinal rupture was found in the proximal area, from the proximal bond to proximal marker band, which measured approximately 4.2mm.The distal end of the longitudinal rupture appears to have scratches on the surface.One side of the rupture shows a material flap, folded outward, with jagged edges on the lower side of the material.A guidewire advanced through the catheter without any resistance, indicating no constriction in the inner lumen.A lot history review revealed this is the only complaint associated with balloon rupture for 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 a longitudinal material rupture in the proximal cone of the balloon, which appears to have scratches on the surface, as well as one side of the rupture shows a material flap, folded outward, with jagged edges on the lower side of the material.In the hcp opinion, the patient's anatomy and calcific nature of the lesion possibly caused each material rupture on both lutonix dcbs used during the procedure.It is unknown if patient and/or procedural issues contributed to the reported event.If additional information becomes available, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters allegedly ruptured longitudinally before reaching nominal pressure, while treating the same target lesion.The health care professional (hcp) used a contralateral approach to treat a calcified target lesion in the superficial femoral artery (sfa).The hcp predilated the calcified target lesion with a 4mm non-dcb balloon.The hcp attempted to inflate the first lutonix dcb to treat the calcified target lesion, but it ruptured before reaching nominal pressure.The hcp then took another lutonix dcb, without any additional predilation of the target lesion, and advanced it to the target lesion.The hcp attempted to inflate the second lutonix dcb to treat the calcified target lesion, but it also ruptured prior to reaching nominal pressure.Both balloons were removed without difficulty.In the hcp opinion, the patient's anatomy and calcific nature of the lesion possibly caused both material ruptures on the lutonix dcb's.The lutonix dcb's were returned for evaluation.No adverse patient outcomes were reported.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00127.

• 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: 6664408
• Report Number: 3006513822-2017-00126
• Device Sequence Number: 46582
• Product Code: ONU
• UDI-Device Identifier: 00801741123207
• UDI-Public: (01)00801741123207(17)200221(10)GFBP3119
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: 9004
• Device Catalogue Number: LX351305605F
• Device Lot Number: GFBP3119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 127