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

Model Number 9004

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

The sample is being returned to the manufacturer at this time; therefore, evaluation is anticipated but has not yet begun.The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: the actual sample has not been received, but is anticipated to be returned for evaluation.Upon completion of the investigation, a supplement report will be submitted with all relevant information.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

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was unable to be deflated after successful treatment of the target lesion.The health care professional (hcp) used a contralateral approach with a 6 french introducer sheath and a 035 terumo guidewire.The hcp predilated the target lesion successfully.The lutonix dcb was prepared in the normal fashion and was flushed.The peel away balloon protector was removed.The lutonix dcb inflated without issues, but it was unable to be completely deflated.The hcp decided to remove the balloon slowly from the patient.After removal of the balloon, the hcp noted the balloon appeared twisted.No adverse patient effects were reported.

Manufacturer Narrative

Analysis: microscopic visual inspection revealed focal necking of the inner lumen, which was evident at three separate locations.The first location was approximately 50 mm proximal from the proximal marker band and the second was next to the proximal balloon bond.The third was within the hub of the catheter.These areas may have been where the hcp held the shaft during insertion of the balloon into the introducer sheath.Focal necking was also present within the catheter hub.The outer and inner shafts were kinked at the strain relief.The balloon was bent and the proximal end of the balloon was accordioned.Conclusion: returned product analysis confirmed the deflation issue of the lutonix dcb.Focal necking was present in three separate locations along the length of the catheter.The balloon was able to fully inflate, but when negative pressure was applied, the rate of deflation was slow.The use environment and/or technique used to obtain the desired location within the target lesion may have caused or contributed to the slow deflation rate of the balloon after treatment.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.

• 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: 5214792
• MDR Text Key: 30978899
• Report Number: 3006513822-2015-00052
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088391
• UDI-Public: (01)00801741088391(17)170331(10)GFZC3956
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 9004
• Device Catalogue Number: 9020410500100
• Device Lot Number: GFZC3956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2015
• 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