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

Model Number 9004

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2016

Event Type  malfunction  

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 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.

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 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
• 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): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 5827708
• MDR Text Key: 50616639
• Report Number: 3006513822-2016-00149
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741109454
• UDI-Public: (01)00801741109454(17)171201(10)LUZM0053A
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• 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