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	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample has been requested to be returned to the manufacturer but has not been received; therefore, an evaluation is anticipated, but has not yet begun.A lot history review revealed this is the only complaint associated with material 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 actual sample has not been received for evaluation.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause for the rupture could not be determined.It is unknown if procedural issues contributed to the reported event.If additional information and/or the sample is received, 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 that during an angioplasty procedure of a non-calcified common iliac artery, with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, allegedly the balloon ruptured before being inflated to nominal pressure.The health care professional (hcp) gained patient access through the patient's right groin with a 7 french cordis brite tip introducer sheath over an angio dynamics j-tip guidewire.The hcp predilated the target lesion with a boston scientific mustang balloon.It is unknown if the hcp applied negative pressure to the lutonix dcb prior to or during advancement to the target lesion.The hcp retracted the ruptured balloon without further complications.Another lutonix dcb was used to complete the patient's procedure.The sample will be requested to be returned for evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: the event description was changed from "the sample will be requested to be returned for evaluation." to "the sample was returned for evaluation." analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter which revealed no identifiable damage.Functional testing of the balloon portion of the catheter was performed revealing a longitudinal material rupture was present from the distal to the proximal balloon bonds.The edges of the longitudinal material rupture were smooth.A lot history review revealed this is the only complaint associated with material 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 actual sample has been received for evaluation.A longitudinal material rupture was present through the entire length of the balloon.The hcp retracted the ruptured balloon from the patient without complications.It is unknown if the hcp applied negative pressure to the lutonix dcb prior to or during advancement to the target lesion.The hcp reported the balloon ruptured prior to being inflated to nominal pressure based on the original report, although, writing on the outer box presents the balloon was likely inflated to 10-11 atmospheres during the procedure.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause for the rupture could not be determined.It is unknown if procedural issues contributed to the reported event.If additional information and/or the sample is received, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported that during an angioplasty procedure of a non-calcified common iliac artery, with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, allegedly the balloon ruptured before being inflated to nominal pressure.The health care professional (hcp) gained patient access through the patient's right groin with a 7 french cordis brite tip introducer sheath over an angio dynamics j-tip guidewire.The hcp predilated the target lesion with a boston scientific mustang balloon.It is unknown if the hcp applied negative pressure to the lutonix dcb prior to or during advancement to the target lesion.The hcp retracted the ruptured balloon without further complications.Another lutonix dcb was used to complete the patient's procedure.The sample was returned for evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: the event description was changed from "it was reported that during an angioplasty procedure of a non-calcified common iliac artery,." to "it was reported that during an off-label angioplasty procedure of a non-calcified common iliac artery,." as well as the event description changed from "the sample will be requested to be returned for evaluation." to "the sample was returned for evaluation." analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter which revealed no identifiable damage.Functional testing of the balloon portion of the catheter was performed revealing a longitudinal material rupture was present from the distal to the proximal balloon bonds.The edges of the longitudinal material rupture were smooth.A lot history review revealed this is the only complaint associated with material 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 actual sample has been received for evaluation.A longitudinal material rupture was present through the entire length of the balloon.The hcp retracted the ruptured balloon from the patient without complications.It is unknown if the hcp applied negative pressure to the lutonix dcb prior to or during advancement to the target lesion.The hcp reported the balloon ruptured prior to being inflated to nominal pressure based on the original report, although, writing on the outer box presents the balloon was likely inflated to 10-11 atmospheres during the procedure.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause for the rupture could not be determined.It is unknown if procedural issues contributed to the reported event.If additional information and/or the sample is received, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported that during an off-label angioplasty procedure of a non-calcified common iliac artery, with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, allegedly the balloon ruptured before being inflated to nominal pressure.The health care professional (hcp) gained patient access through the patient's right groin with a 7 french cordis brite tip introducer sheath over an angio dynamics j-tip guidewire.The hcp predilated the target lesion with a boston scientific mustang balloon.It is unknown if the hcp applied negative pressure to the lutonix dcb prior to or during advancement to the target lesion.The hcp retracted the ruptured balloon without further complications.Another lutonix dcb was used to complete the patient's procedure.The sample was returned for evaluation.No adverse patient effects 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: 7571344
• Report Number: 3006513822-2018-00140
• Device Sequence Number: 1980254
• Product Code: PRC
• UDI-Device Identifier: 00801741135484
• UDI-Public: (01)00801741135484
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2018

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: 05/30/2019
• Device Model Number: 9010
• Device Catalogue Number: LX3575940V
• Device Lot Number: GFBS3457
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/29/2018; 07/20/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/19/2018; 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 130