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

Model Number 9004

Device Problems Retraction Problem (1536); Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

Analysis/device evaluation: upon receipt, visual examination of the catheter revealed multiple kinks along the length of the catheter.Further inspection noted the distal end of the balloon portion was returned with the device.Examination of the balloon material noted it was torn with jagged edges and surface abrasions at the initiation of the torn balloon material.The inner lumen is severely stretched and the proximal marker band is displaced and damaged in a slight oval shape.The distal end of the returned inner lumen is torn and the edges are jagged.There is shearing damage, proximal to the distal end of the inner lumen.Due to the returned condition of the device performance testing was unable to be performed.A lot history review revealed this is the only complaint associated with allegations of material rupture with retraction issues resulting in device separation 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.Conclusion: returned product analysis confirmed the reported material rupture and difficulty re-sheathing the balloon.Based on the information provided and analysis results, the material rupture was likely caused by treating a calcified non-target lesion in the common iliac artery.The force applied to the catheter during removal though the introducer sheath likely contributed to the balloon material separating from the catheter.There was nothing found to indicate there was a design, manufacturing or component anomaly which would have caused or contributed to this event.If additional information becomes available, a supplement report will be submitted with all relevant information.

Event Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured on its second inflation at 14 atmospheres (atms) while treating a non-target lesion in the common iliac.The health care professional (hcp) used a contralateral approach with a 7 french ansel introducer sheath over an unknown 035 guidewire to treat the target lesion in the superficial femoral artery (sfa).The hcp reportedly used a hawk one atherectomy over an 014 guidewire to prepare the target lesion in the sfa.Reportedly, the 014 guidewire was exchanged for an 035 guidewire in preparation to advance the lutonix 035 catheter.The hcp then reached the target lesion with the lutonix dcb and allegedly inflated the device to 8 atms.After successful treatment of the sfa, the hcp pulled the lutonix dcb to a stenosed region of the common iliac artery and inflated the lutonix dcb to 14 atms.Reportedly, the lutonix dcb ruptured during this inflation attempt.Upon attempts to remove the device, reportedly the balloon would not re-sheath, resulting in the balloon portion becoming stuck in the introducer sheath.Eventually, the hcp tore the balloon and the balloon portion became lodged in the common iliac artery over the aortic bifurcation.The hcp obtained an additional access from the opposite side of the original patient access.The balloon portion was reportedly fixated to the artery wall with two kissing stents which completed the procedure.The lutonix dcb was returned for evaluation.No further adverse patient outcomes were reported.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 8531615
• MDR Text Key: 142493778
• Report Number: 3006513822-2019-00060
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741123245
• UDI-Public: (01)00801741123245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFBY1837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 71