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

Model Number	9004
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2016
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 revealing the catheter was in four separate pieces.The first piece, balloon portion and the inner lumen, were approximately separated proximal to middle of the balloon.The proximal end of balloon was stretched with proximal marker band dislocation.The inner lumen was accordioned.Multiple kinks were found throughout the shaft length, along with the inner lumen collapsed at one point.The second piece, catheter's inner and outer shaft, were torn apart proximal to the proximal balloon bond from the other length of the catheter.The inner lumen was severely stretched, due to focal necking of the catheter's shaft.The third piece, catheter's main shaft length, was longer than anticipated, due to the inner shaft severely stretched.The fourth piece, hub section, was separated at the outer shaft hub bond and the inner shaft was severely accordioned and stretched.The damage was the result of the inner shaft being torn from the main catheter length.No functional testing could be performed due to the condition of the catheter.A lot history review revealed this is the only complaint associated with 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 catheter was difficult to remove, and while the health care professional (hcp) was removing the catheter by force, the catheter was completely torn apart into multiple pieces.Based on the information provided, the four pieces in which the catheter was torn into is most likely due to the hcps retraction technique and force applied during their attempts to remove the catheter.Other contributing factors may have been related to patient complex anatomy and the patient's overall disease state.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause for the difficulty the physician experienced during the removal could not be determined, but the root cause for the returned condition of the catheter was the result of the hcp retraction technique and extreme force used to remove the catheter through the introducer sheath.Other contributing factors may have been related to patient complex anatomy and the patient's overall disease state.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 or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly tore during retraction, after treatment of a very calcified superficial femoral artery (sfa), making it difficult to remove.The health care professional (hcp) used a contralateral approach to treat the left sfa.After treatment, the hcp applied negative pressure to completely deflate the balloon which the hcp verified under fluoroscopy.The catheter was retracted, but became stuck about three centimeters before the end of the introducer sheath.The hcp attempted to remove the catheter for approximately ten minutes.In the end, the hcp tore the catheter apart.The physician removed the complete catheter from the patient.The lutonix dcb was returned for further evaluation.There was no patient injury 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: 6261096
• Report Number: 3006513822-2017-00005
• Device Sequence Number: 955612
• Product Code: ONU
• UDI-Device Identifier: 00801741088476
• UDI-Public: (01)00801741088476(17)190731(10)GFAU3537
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2016

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: 07/31/2019
• Device Model Number: 9004
• Device Catalogue Number: 9020410500150
• Device Lot Number: GFAU3537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 65