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

Model Number	9004
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed the catheter shaft was kinked in two locations and one location of focal necking of the inner lumen, approximately 52.2cm from the proximal bond.The middle of the balloon was wrinkled and the inner lumen was accordioned at a similar location.Functional testing of the returned sample revealed the returned guidewire was able to be completely advanced through the inner lumen of the catheter with some resistance.The resistance was consistent with the location of the accordioned inner lumen damage.The balloon was also attempted to be inflated, which revealed a material rupture in the proximal cone of the balloon.The material rupture was crescent shape in nature with a distinct central material flap.Furthermore, the material rupture was surrounded by scratches.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 a material rupture in the proximal cone of the balloon.The material rupture was crescent shape in nature with a distinct central material flap.Furthermore, the material rupture was surrounded by scratches.There was nothing found to indicate there was a manufacturing related cause for this event.In the physician's opinion, he does not believe the patient's calcified anatomy caused or contributed to the lutonix dcb¿s material rupture.Although requested, it is unknown if negative pressure was applied prior to the removal of the lutonix dcb.Thus, a definitive root cause could not be determined based on the information provided.It is unknown if patient and/or procedural issues contributed to the reported event.If additional information is received, 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 or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly had a material rupture occur after treating the target lesion.The health care professional (hcp) used a contralateral approach to gain patient access and the target lesion was successfully predilated.The hcp advanced the lutonix dcb to the target lesion and inflated the balloon to treat the target lesion successfully.The specific inflation pressure of the balloon is unknown, but the balloon was not inflated greater than rate burst pressure (rbp).As the hcp attempted to remove the lutonix dcb, it became stuck in the introducer sheath, thus the entire catheter and the introducer sheath were removed as a single unit.Although requested, it is unknown if negative pressure was applied prior to the removal of the lutonix dcb.Furthermore, the hcp does not believe that patient anatomy or calcification of the vessel is related to the nature of the reported material rupture.No adverse patient outcomes were reported.
Additional Manufacturer Narrative
Event description changed from "it was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly had a material rupture occur after treating the target lesion.The health care professional (hcp) used a contralateral approach to gain patient access and the target lesion was successfully predilated.The hcp advanced the lutonix dcb to the target lesion and inflated the balloon to treat the target lesion successfully.The specific inflation pressure of the balloon is unknown, but the balloon was not inflated greater than rate burst pressure (rbp).As the hcp attempted to remove the lutonix dcb, it became stuck in the introducer sheath, thus the entire catheter and the introducer sheath were removed as a single unit.Although requested, it is unknown if negative pressure was applied prior to the removal of the lutonix dcb.Furthermore, the hcp does not believe that patient anatomy or calcification of the vessel is related to the nature of the reported material rupture.No adverse patient outcomes were reported." to "it was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly had a material rupture occur after treating the target lesion.The health care professional (hcp) used a contralateral approach to gain patient access and the target lesion was successfully predilated.The hcp advanced the lutonix dcb to the target lesion and inflated the balloon to treat the target lesion successfully.The specific inflation pressure of the balloon is unknown, but the balloon was not inflated greater than rate burst pressure (rbp).The hcp applied negative pressure to the lutonix dcb prior to removing the device.As the hcp attempted to remove the lutonix dcb, it became stuck in the introducer sheath, thus the entire catheter and the introducer sheath were removed as a single unit.Furthermore, the hcp does not believe that patient anatomy or calcification of the vessel is related to the nature of the reported material rupture.No adverse patient outcomes were reported." analysis/device evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed the catheter shaft was kinked in two locations and one location of focal necking of the inner lumen, approximately 52.2cm from the proximal bond.The middle of the balloon was wrinkled and the inner lumen was accordioned at a similar location.Functional testing of the returned sample revealed the returned guidewire was able to be completely advanced through the inner lumen of the catheter with some resistance.The resistance was consistent with the location of the accordioned inner lumen damage.The balloon was also attempted to be inflated, which revealed a material rupture in the proximal cone of the balloon.The material rupture was crescent shape in nature with a distinct central material flap.Furthermore, the material rupture was surrounded by scratches.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 a material rupture in the proximal cone of the balloon.The material rupture was crescent shape in nature with a distinct central material flap.Furthermore, the material rupture was surrounded by scratches.There was nothing found to indicate there was a manufacturing related cause for this event.In the physician's opinion, he does not believe the patient's calcified anatomy caused or contributed to the lutonix dcb¿s material rupture.Although requested, it is unknown if negative pressure was applied prior to the removal of the lutonix dcb.Thus, a definitive root cause could not be determined based on the information provided.It is unknown if patient and/or procedural issues contributed to the reported event.If additional information is received, 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 had a material rupture occur after treating the target lesion.The health care professional (hcp) used a contralateral approach to gain patient access and the target lesion was successfully predilated.The hcp advanced the lutonix dcb to the target lesion and inflated the balloon to treat the target lesion successfully.The specific inflation pressure of the balloon is unknown, but the balloon was not inflated greater than rate burst pressure (rbp).The hcp applied negative pressure to the lutonix dcb prior to removing the device.As the hcp attempted to remove the lutonix dcb, it became stuck in the introducer sheath, thus the entire catheter and the introducer sheath were removed as a single unit.Furthermore, the hcp does not believe that patient anatomy or calcification of the vessel is related to the nature of the reported material rupture.No adverse patient outcomes 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: 7325770
• Report Number: 3006513822-2018-00047
• Device Sequence Number: 16169037
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: 08/31/2019
• Device Model Number: 9004
• Device Catalogue Number: 9050613500150
• Device Lot Number: GFBN3839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/11/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1