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	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample was discarded at the user facility; therefore, an evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with material rupture for this lot.A device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.There was nothing found to indicate there was a manufacturing related cause for this event.Although requested, additional event details were unavailable.Thus, a definitive root cause could not be determined based on the information provided.It is unknown if patient and/or procedural issues contributed to the reported event.If additional information 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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating a non calcified target lesion in the superficial femoral artery (sfa).The health care professional (hcp) retracted the lutonix dcb through the introducer sheath without issues.The hcp used a new balloon, which was prepped in the normal fashion, and used to complete the patient's procedure.Although requested, additional event details were unavailable.The lutonix dcb was discarded by the user facility and is not available 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 while treating a non-calcified target lesion in the superficial femoral artery (sfa).The health care professional (hcp) gained patient access through a contralateral approach.The hcp prepared the target lesion with atherectomy, followed by predilation.The hcp determined the target lesion preparation was very successful.The lutonix dcb was allegedly used to treat the target lesion, but as the hcp attempted to inflate the balloon, it would not inflate.The hcp retracted the lutonix dcb through the introducer sheath without issues.The hcp used a new balloon, which was prepared in the normal fashion, and used to complete the patient's procedure.The hcp believes the anatomy and calcification is not related to the rupture, since the target lesion preparation was very successful.The lutonix dcb was discarded by the user facility and is not available for evaluation.No adverse patient outcomes were reported.
Additional Manufacturer Narrative
Event date was added to (b)(6) 2018.The event description was changed from "it was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating a non calcified target lesion in the superficial femoral artery (sfa).The health care professional (hcp) retracted the lutonix dcb through the introducer sheath without issues.The hcp used a new balloon, which was prepped in the normal fashion, and used to complete the patient's procedure.Although requested, additional event details were unavailable.The lutonix dcb was discarded by the user facility and is not available for evaluation.No adverse patient outcomes were reported." to "it was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating a non-calcified target lesion in the superficial femoral artery (sfa).The health care professional (hcp) gained patient access through a contralateral approach.The hcp prepared the target lesion with atherectomy, followed by predilation.The hcp determined the target lesion preparation was very successful.The lutonix dcb was allegedly used to treat the target lesion, but as the hcp attempted to inflate the balloon, it would not inflate.The hcp retracted the lutonix dcb through the introducer sheath without issues.The hcp used a new balloon, which was prepared in the normal fashion, and used to complete the patient's procedure.The hcp believes the anatomy and calcification is not related to the rupture, since the target lesion preparation was very successful.The lutonix dcb was discarded by the user facility and is not available for evaluation.No adverse patient outcomes were reported." analysis: the sample was discarded at the user facility; therefore, an evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with material rupture for this lot.A device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.There was nothing found to indicate there was a manufacturing related cause for this event.The hcp believes the anatomy and calcification is not related to the rupture, since the target lesion preparation was very successful.Thus, a definitive root cause could not be determined based on the information provided.It is unknown if patient and/or procedural issues contributed to the reported event.If additional information is received, a supplement report will be submitted with all relevant information.

• 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: 7344746
• Report Number: 3006513822-2018-00050
• Device Sequence Number: 16722410
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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: 09/25/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513061505F
• Device Lot Number: GFBW2259
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 95