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

Model Number 9004

Device Problems Retraction Problem (1536); Torn Material (3024)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

Analysis/device evaluation: upon receipt of the sample, visual examination of the catheter was complete, which revealed the inflation hub was cracked and the catheter shaft was kinked.The proximal marker band is in the wrong location, proximal to the correct location, and the proximal balloon cone is severely wrinkled.The proximal third of the balloon is attached to the catheter, but the remaining length of the balloon was not returned.The distal end of the returned balloon is torn as well as an additional circumferential tear approximately 35 mm from the proximal balloon bond.Under magnification, the tear has jagged edges and a burr, which is likely the initial contact point of the stent and the balloon.The inner shaft is kinked and twisted with the distal end severely accordioned.The distal end of the returned inner shaft is also torn with the distal tip and marker band not returned for evaluation.Functional testing of the balloon was unable to be performed due to the condition of the returned device.A lot history review revealed this is the only complaint associated with balloon 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 retraction issues resulting in severe damage to the balloon.Analysis of the returned device supports the physicians suspicion of the balloon becoming caught on a previously placed ten year old stent in the right common iliac artery.Under magnification, approximately 35 mm from the proximal balloon bond, a circumferential tear with jagged edges and a burr, is most likely the initial contact point of the stent and the balloon.The inner lumen is severely stretched, which provides evident associated with an increase force used by the operator to retract the balloon.Due to these factors, the balloon and inner lumen at different points tore circumferentially at a diagonal which completely separated the device into two pieces.There was nothing found to indicate there was a manufacturing related cause for this event.Although evaluation revealed a crack in the inflation hub, it is unknown when that crack occurred.The physician reported the balloon was completely deflated.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 Description

After treatment of the target lesion, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was allegedly torn during removal of the catheter from the patient.The health care professional (hcp) used a contralateral approach with a 6 french introducer sheath and guide catheter over a mach one boston scientific guidewire to treat the right superficial femoral artery (sfa).Reportedly, after treatment, the hcp deflated the lutonix balloon completely and began to remove the catheter from the patient's vessel, but the balloon portion became stuck.While attempting to remove the balloon a fragment of the balloon remained inside the patient.The hcp suspects the balloon caught on a previously placed ten year old stent in the right common iliac artery.The physician extended the procedure to place an additional stent to secure the piece of torn balloon to the artery wall.The lutonix dcb was returned for further evaluation.No further adverse patient effects 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: 6402003
• MDR Text Key: 69850373
• Report Number: 3006513822-2017-00046
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759(17)190430(10)GFAQ0518
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 9004
• Device Catalogue Number: 9020413500150
• Device Lot Number: GFAQ0518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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: 77 YR