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	08/28/2017
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 heavy dry blood residue within the inflation lumen.The proximal area of the balloon was severely wrinkled and the middle of the balloon was bulged.Under 10-30x magnification, a longitudinal rupture was identified in the middle of the balloon, approximately 38 mm from distal tip of the catheter.The longitudinal rupture was 6 mm long and was found under a folded area of the balloon.Due to the heavy dry blood residue, functional testing was unable to be performed.A lot history review revealed there are no similar complaints 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: returned product analysis confirmed the material rupture was longitudinal in nature and was 6 mm long in the middle of the balloon.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.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 prior to inflation.The health care professional (hcp) used a contralateral approach through the right common femoral artery to treat the target lesion in the left superficial femoral artery (sfa).The hcp predilated the target lesion prior to the lutonix dcb treatment.The hcp advanced the lutonix dcb to the target lesion, under negative pressure.The hcp reported blood infiltrating the endoflator prior to inflating the lutonix dcb, which the hcp believed indicates a "hole" was present in the balloon.The lutonix dcb was removed intact and another lutonix dcb was used to complete the procedure.Although requested, the target lesion and vessel morphology are unknown.The lutonix dcb was 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: 6935128
• Report Number: 3006513822-2017-00188
• Device Sequence Number: 13758599
• Product Code: ONU
• UDI-Device Identifier: 00801741123207
• UDI-Public: (01)00801741123207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/10/2017

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: 04/29/2018
• Device Model Number: 9004
• Device Catalogue Number: LX351305605F
• Device Lot Number: GFAQ0526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 84