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

Model Number	9010
Medical Device Problem Codes	Deflation Problem (1149); Material Rupture (1546)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample has been requested for evaluation, but has not been received.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.Conclusion: the sample has been requested for evaluation, but has not been received.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 would not deflate after successfully treating the target lesion in the cephalic av fistula.The health care professional (hcp) attempted to use an inflation device to get the lutonix balloon to collapse on itself, switched to a syringe, but neither of these attempts were successful in deflating the balloon.Finally, the hcp reportedly attempted to rupture the balloon, but in the process the av fistula allegedly ruptured.The hcp repaired the ruptured av fistula with a covered stent.Although requested, it is unknown how the lutonix dcb was removed from the patient.The lutonix dcb was requested to be returned for evaluation.No further adverse outcomes were reported.
Additional Manufacturer Narrative
The event description was changed from "it was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly would not deflate after successfully treating the target lesion in the cephalic av fistula.The health care professional (hcp) attempted to use an inflation device to get the lutonix balloon to collapse on itself, switched to a syringe, but neither of these attempts were successful in deflating the balloon.Finally, the hcp reportedly attempted to rupture the balloon, but in the process the av fistula allegedly ruptured.The hcp repaired the ruptured av fistula with a covered stent.Although requested, it is unknown how the lutonix dcb was removed from the patient.The lutonix dcb was requested to be returned for evaluation.No further adverse outcomes were reported." to "it was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly would not deflate after successfully treating the target lesion in the cephalic av fistula.The health care professional (hcp) predilated the target lesion prior to treatment with the lutonix dcb.The hcp prepared the lutonix dcb by removing the balloon protector without issues.The hcp used a 70/30 saline/contrast solution to inflate the lutonix dcb to nominal pressure.After the treatment period passed, the hcp attempted to use an inflation device to get the lutonix balloon to collapse on itself, but allegedly the balloon would not deflate.The hcp reportedly switched to a syringe, but neither of these attempts were successful in deflating the balloon.The length of time it took to deflate the balloon was not officially measured.Finally, the hcp reportedly attempted to rupture the balloon by inflating the catheter a little above nominal pressure, and in the process the av fistula allegedly ruptured.It is unknown what alleged device was used to inflate the balloon's catheter a little above nominal pressure.The hcp removed the ruptured balloon through the patient access.Immediately, the hcp repaired the ruptured av fistula with a covered stent.Although requested, the patient weight is unavailable.The lutonix dcb was retained by the hospital's risk management department and is not available for evaluation.No further adverse outcomes were reported." (b)(4).Analysis: the sample has been retained by the user facilities risk management department, and is not available for evaluation at this time.A lot history review revealed this is the only complaint associated with deflation issue 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.Conclusion: the actual sample has not been received, the sample is being retained by the user facility.The dhr found nothing to indicate a manufacturing related cause for this event.Reportedly, the health care professional (hcp) attempted multiple times with multiple devices to deflate the lutonix dcb without success.Allegedly, the length of time it took to deflate the balloon was not officially measured.Finally, the hcp reportedly attempted to rupture the balloon by inflating the device a little above nominal pressure, and in the process the av fistula allegedly ruptured.It is unknown what alleged device was used to inflate the balloon's catheter a little above nominal pressure.The hcp removed the ruptured balloon through the patient access.Immediately, the hcp repaired the ruptured av fistula with a covered stent.Based on the information available, a definitive root cause for the reported deflation issue is unable to be determined.The reported ruptured vessel is possibly related to the hcp attempt to rupture the catheter's balloon.If additional information is received or the sample is returned, a supplemental 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 would not deflate after successfully treating the target lesion in the cephalic av fistula.The health care professional (hcp) predilated the target lesion prior to treatment with the lutonix dcb.The hcp prepared the lutonix dcb by removing the balloon protector without issues.The hcp used a 70/30 saline/contrast solution to inflate the lutonix dcb to nominal pressure.After the treatment period passed, the hcp attempted to use an inflation device to get the lutonix balloon to collapse on itself, but allegedly the balloon would not deflate.The hcp reportedly switched to a syringe, but neither of these attempts were successful in deflating the balloon.The length of time it took to deflate the balloon was not officially measured.Finally, the hcp reportedly attempted to rupture the balloon by inflating the catheter a little above nominal pressure, and in the process the av fistula allegedly ruptured.It is unknown what alleged device was used to inflate the balloon's catheter a little above nominal pressure.The hcp removed the ruptured balloon through the patient access.Immediately, the hcp repaired the ruptured av fistula with a covered stent.Although requested, the patient weight is unavailable.The lutonix dcb was retained by the hospital's risk management department and is not available for evaluation.No further adverse outcomes were reported.

• Brand Name: LUTONIX 035AV 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: 8177429
• Report Number: 3006513822-2018-00289
• Device Sequence Number: 11063540
• Product Code: PRC
• UDI-Device Identifier: 00801741135453
• UDI-Public: (01)00801741135453
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2019
• Device Model Number: 9010
• Device Catalogue Number: LX3575840V
• Device Lot Number: GFBS2141
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR