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

Model Number	9004
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter which revealed a bulge at the 59 cm geomarker.The proximal balloon bond is slightly wrinkled.Functional testing was performed by inflating the balloon which revealed multiple material ruptures in the proximal third(x 4) and distal third(x 1) of the balloon, thus a total of 5 ruptures were identified during the preliminary 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.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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was allegedly unable to be inflated due to a circumferential rupture at the proximal end of the balloon.The health care professional (hcp) used the left common femoral artery as a contralateral approach to gain patient access with 6 french cook ansel introducer sheath over an 035 advantage guidewire to treat the right superficial femoral artery (sfa).Reportedly, the hcp did not predilate the target lesion.The hcp prepared the lutonix dcb in the normal fashion and removed the balloon protector without issues.Allegedly, the hcp advanced the lutonix dcb to the calcified aortic bifurcation, but had difficultly traversing the calcified region.Reportedly, negative pressure was not established prior to the advancement of the lutonix dcb to the target lesion.The hcp was able to cross the aortic bifurcation and reached the target lesion, but allegedly the lutonix dcb balloon would not inflate.The hcp removed the lutonix dcb successfully.Reportedly, a laser atherectomy was performed after upsizing the introducer sheath and the target lesion was treated with a different manufacturers device to complete the procedure.The lutonix dcb was requested to be returned for evaluation.No adverse patient outcomes were reported.
Additional Manufacturer Narrative
Returned product analysis confirmed multiple small material ruptures in the proximal and distal balloon areas.The balloon was severely wrinkled and bunched in the proximal balloon area with associated surface scratches.Three holes were identified under magnification in the proximal balloon area associated with scratches near each hole.One of the three holes was on the opposite side of the balloon than the other two holes.The hole identified in the distal balloon area appeared to be crescent shaped.Analysis/preliminary evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter which revealed a bulge at the 59 cm geomarker.The proximal balloon bond is slightly wrinkled.Functional testing was performed by inflating the balloon which revealed multiple material ruptures in the proximal third(x 4) and distal third(x 1) of the balloon, thus a total of 5 ruptures were identified during the preliminary 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.Conclusion: the returned sample confirmed multiple small material ruptures in the proximal and distal balloon areas, which were either circular or crescent shaped.During advancement to the target lesion, the health care professional (hcp) had difficulty traversing the calcified aortic bifurcation, but did reach the target lesion.Negative pressure of the lutonix dcb was not applied by the hcp.The allegation of circumferential material rupture was unconfirmed.It is possible the balloon was damaged while the hcp was traversing the calcified aortic bifurcation.There was nothing found to indicate there was a manufacturing related cause for this event.If additional information becomes available, 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 was allegedly unable to be inflated due to a circumferential rupture at the proximal end of the balloon.The health care professional (hcp) used the left common femoral artery as a contralateral approach to gain patient access with 6 french cook ansel introducer sheath over an 035 advantage guidewire to treat the right superficial femoral artery (sfa).Reportedly, the hcp did not predilate the target lesion.The hcp prepared the lutonix dcb in the normal fashion and removed the balloon protector without issues.Allegedly, the hcp advanced the lutonix dcb to the calcified aortic bifurcation, but had difficulty traversing the calcified region.Reportedly, negative pressure was not established prior to the advancement of the lutonix dcb to the target lesion.The hcp was able to cross the aortic bifurcation and reached the target lesion, but allegedly the lutonix dcb balloon would not inflate.The hcp removed the lutonix dcb successfully.Reportedly, a laser atherectomy was performed after upsizing the introducer sheath and the target lesion was treated with a different manufacturers device to complete the procedure.The lutonix dcb was requested to be returned for evaluation.No adverse patient outcomes 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: 6786268
• Report Number: 3006513822-2017-00154
• Device Sequence Number: 18983528
• Product Code: ONU
• UDI-Device Identifier: 00801741123245
• UDI-Public: (01)00801741123245
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/11/2017

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: 03/07/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFBQ1423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR