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	03/22/2019
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 kink at the distal end of the strain relief and heavy blood residue in the inflation lumen.Functional testing determined the balloon was unable to maintain negative pressure nor would the balloon inflate.Under microscope evaluation, a longitudinal "l" shaped material rupture was identified.The distal end of the material rupture, which was perpendicular to the length of the balloon, was 18 mm from the distal marker band.The material rupture extended for the next 95 mm to the proximal end of the balloon.The distal end of the rupture, which was perpendicular to the length of the balloon had jagged edges.Lot history review revealed this is the only complaint related to this corporate lot number gfdn2638.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis confirmed a longitudinal "l" shaped material rupture extending for 95 mm.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The health care professional (hcp) reported the target lesion was heavily calcified.In the opinion of the hcp, the heavily calcified lesion may be the reason for the material rupture.Therefore, the known information from the hcp and the returned sample provides both confirmation of the reported event, and leads to the possibility that the longitudinal material rupture is consistent with use in a heavily calcified target lesion.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 allegedly rupture at 7 atmospheres (atms) while treating a heavily calcified target lesion in the left superficial femoral artery (sfa).The health care professional (hcp) used a contralateral approach to gain patient access with a 6 french cook introducer sheath over an 018 terumo guidewire to access the target lesion.The hcp predilated the lesion successfully.The hcp prepared the lutonix dcb by removing the balloon protector without issues.The hcp advanced the lutonix dcb to the left sfa, under negative pressure, and inflated the balloon to nominal pressure of 7 atms.Once at full inflation, the balloon started to deflate.In the opinion of the hcp, the heavily calcified lesion may be the reason for the material rupture.The hcp also noted it could be a pinhole rupture in the balloon.Another lutonix dcb was used to complete the procedure.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: 8542603
• Report Number: 3006513822-2019-00061
• Device Sequence Number: 1731123
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/23/2019

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: 01/21/2022
• Device Model Number: 9004
• Device Catalogue Number: LX3513061505F
• Device Lot Number: GFDN2638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 90