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

Model Number	9004
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/sample evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter revealing the inflation port of the hub was cracked and the thread of the port was damaged.Functional testing revealed negative pressure was unable to be applied to the balloon.Solution also leaked from the inflation port when the balloon was attempted to be inflated.A lot history review revealed this is the only complaint associated with this lot.Conclusion: returned product analysis confirmed the inflation port on the hub was cracked with additional damage resulting in the catheter unable to perform its essential function.A definitive root cause could not be determined.It is unknown if procedural issues contributed to the reported event.Upon completion of the investigation, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly separated at the catheters hub.The health care professional (hcp) noticed the hub separation/fracture while attempting to inflate the balloon to treat the patient's target lesion.The hub separated outside of the body and the rest of the catheter was able to be retracted from the patient without difficulty, while maintaining access.Another drug coated balloon was used to complete the procedure.The hcp is not a first time user and they did feel the training was adequate.The lutonix dcb was returned for further evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
"separation" was corrected with "split." "the hub separated outside of the body and the rest of the catheter was able to be retracted from the patient without difficulty" was corrected with "the catheter was completely removed," analysis/sample evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter revealing the inflation port of the hub was cracked and the thread of the port was damaged.Functional testing revealed negative pressure was unable to be applied to the balloon.Solution also leaked from the inflation port when the balloon was attempted to be inflated.A lot history review revealed this is the only complaint associated with this lot.A dhr review was performed and noted the device was manufactured to specification prior to being released for distribution.Conclusion: returned product analysis confirmed the inflation port on the hub was cracked with additional damage resulting in the catheter unable to perform its essential function.A definitive root cause could not be determined.It is unknown if procedural issues contributed to the reported event.Additional conclusion: a review of the manufacturing record show the lot was manufactured to specification.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 split at the catheters hub.The health care professional (hcp) noticed the hub split/fracture during the inflation attempt of the balloon to treat the patient's target lesion.The catheter was completely removed while maintaining patient access.Another drug coated balloon was used to complete the procedure.The hcp is not a first time user and they did feel the training was adequate.The lutonix dcb was returned for further evaluation.No adverse patient effects 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: 5827708
• Report Number: 3006513822-2016-00149
• Device Sequence Number: 346345
• Product Code: ONU
• UDI-Device Identifier: 00801741109454
• UDI-Public: (01)00801741109454(17)171201(10)LUZM0053A
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2016

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: 12/01/2017
• Device Model Number: 9004
• Device Catalogue Number: BSCLX35130760
• Device Lot Number: LUZM0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2016
• Supplement Report FDA Received Date: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1