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

Model Number	9004
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
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.Under magnification, an "s" shaped material rupture was present longitudinal to the length of the balloon length.The edges of the rupture are pushed inwards towards the inner lumen.The returned guidewire was within the inner lumen of the catheter and it was damaged with severe kinks and a bend with intermittent contrast and blood residue.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: returned product analysis confirmed the material rupture is "s" shaped, longitudinal to the length of the balloon length.Additionally, the returned guidewire was within the inner lumen of the catheter and it was damaged with severe kinks and a bend.There was nothing found to indicate there was a manufacturing related cause for this event.In the opinion of the hcp, the calcified anatomy of the target lesion is possibly related to the nature of the rupture.Reportedly, there are no stents present in the target lesion or tracking path.It is unknown if the hcp predilated the target lesion.Therefore, the known information from the hcp and the returned sample provides both confirmation of the reported event, but does not identify the exact root cause(s), although its possibly due to the calcification of the target lesion.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating the calcified target lesion in the superficial femoral artery (sfa) before reaching nominal pressure.The health care professional (hcp) used a contralateral approach to gain access to the target lesion with a bentson guidewire.It is unknown if the hcp predilated the target lesion.The hcp inflated the lutonix dcb to 4 atmospheres (atms) when the hcp noticed the balloon was not inflated.In the opinion of the hcp, the calcified anatomy of the target lesion is possibly related to the nature of the rupture.Reportedly, there are no stents present in the target lesion or tracking path.The hcp used another device to complete the patient's 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: 8478418
• Report Number: 3006513822-2019-00054
• Device Sequence Number: 1633967
• Product Code: ONU
• UDI-Device Identifier: 00801741123283
• UDI-Public: (01)00801741123283
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/03/2019

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: 10/26/2021
• Device Model Number: 9004
• Device Catalogue Number: LX3513061005F
• Device Lot Number: GFCX3313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 74