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

Model Number 9004

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problem Intimal Dissection (1333)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

Analysis/preliminary evaluation: upon receipt of the sample, pre-decontamination testing of the complaint sample was extensively damaged.The complaint sample was decontaminated and prepared for further evaluation.A lot history review revealed this is the only complaint associated with a deflation issue resulting in non-flow limiting vessel dissections 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.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: the returned sample is undergoing evaluation which has not yet been completed.Upon completion of the investigation, 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 Description

It was reported, through a medwatch report from the user facility, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was unable to be completely deflated during a percutaneous transluminal angioplasty (pta) procedure.The partially deflated balloon was unable to be retracted through a 7 french 45 cm introducer sheath.The health care professional (hcp) prepared the target lesion in the left superficial femoral artery (sfa) via atherectomy.The hcp pre-dilated the distal and proximal segments of the target lesion.The hcp used a 035 j-shaped guidewire to deliver the lutonix 035 dcb.During preparation, the hcp noted the 035 guidewire did not easily pass through the inner lumen of the lutonix dcb.The hcp exchanged the 035 j-shaped guidewire for a terumo glidewire, but encountered the same issue.Finally, the hcp successfully passed a 018 stiff command guidewire through the inner lumen and the lutonix dcb was advanced to the target lesion.The hcp noted difficulty passing the 018 guidewire through the hub of the lutonix dcb, specifically where the inner shaft interfaces with the hub.After treating the most distal portion of the target lesion, the hcp decided to use the lutonix dcb to treat the proximal portion of the target lesion, using two inflations of shorter duration.The hcp was unable to completely deflate the balloon after the devices third inflation.The hcp applied negative pressure, but the balloon did not completely deflate.The hcp then attempted to deflate it by using double negative pressure, but was unsuccessful in deflating the balloon.Therefore, the hcp removed the introducer sheath and the lutonix dcb as a single unit.An observer of the procedure stated the hcp retracted the balloon back through a heavily diseased portion of the artery causing non-flow limiting dissections.The hcp completed the procedure by stenting the dissections.The lutonix dcb was returned for evaluation.No adverse patient outcomes were reported.

Manufacturer Narrative

Device evaluation: upon receipt of the sample, a visual examination was performed over the entire length of the catheter which revealed the entire balloon was severely wrinkled.The proximal area of the balloon was pinched, which caused the inner lumen to be constricted, approximately 14mm from the proximal bond.Furthermore, the inner lumen in the proximal area was overlapped and accordioned.The distal portion of the balloon was pulled inside the middle of the balloon.The inner lumen was stretched, with both marker bands shifted proximally from their original locations.Distal marker band distance measured 8mm from the distal bond area.The proximal marker band distance measured 18mm from the proximal bond.Both marker bands have been displaced from their original positions at manufacturing.The shaft was kinked near the 65cm geomarker.The catheter shaft appeared to have heavy blood residue at multiple locations.The catheter was returned with the introducer sheath still attached.The sheath was able to be moved, but could not be removed from the catheter shaft due to the balloon damage.The tip of the introducer sheath was also damaged.The catheter shaft was kinked near the edge of the strain relief, which constricted the inner lumen.The shaft was focally necked for 20mm, starting at the edge of the strain relief to the 125cm geomarker.The inner lumen was accordioned and filled with heavy blood residue inside the hub.Due to the extensive damage, minimal functional testing was able to be performed.An 035 guidewire was attempted to be advanced through the hub, but became stuck in the hub.Next, an attempt was made to advance the 035 guidewire from the distal tip, but the guidewire became stuck between the middle and proximal area of the balloon.Negative pressure was applied, but could not be maintained due to focal necking of the outer shaft.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.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis confirmed the entire balloon was severely wrinkled, the inner lumen was accordioned and stretched, the distal cone of the balloon was pulled inside the distal portion of the balloon, both marker bands were proximally dislocated from the original locations, and the outer shaft was focally necked.The catheter shaft was kinked at the strain relief and the inner lumen was constricted.The damage indicates additional force, more than normal requirements, was applied to retract the balloon.Hence, negative pressure was likely unable to be applied and/or maintained to completely deflate the balloon.Furthermore, if the balloon is not completely deflated and/or negative pressure is not maintained during withdrawal of the balloon, retraction difficulties are likely.Based on the investigation and the returned product analysis, it is possible the catheter was not completely deflated, prior to the hcp's attempt to retract the catheter.It is unknown if patient and/or procedural issues contributed to the reported event.If additional information becomes available, a supplement report will be submitted with all relevant information.

Event Description

It was reported, through a medwatch report from the user facility, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was unable to be completely deflated during a percutaneous transluminal angioplasty (pta) procedure.The partially deflated balloon was unable to be retracted through a 7 french 45 cm introducer sheath.The health care professional (hcp) prepared the target lesion in the left superficial femoral artery (sfa) via atherectomy.The hcp pre-dilated the distal and proximal segments of the target lesion.The hcp used a 035 j-shaped guidewire to deliver the lutonix 035 dcb.During preparation, the hcp noted the 035 guidewire did not easily pass through the inner lumen of the lutonix dcb.The hcp exchanged the 035 j-shaped guidewire for a terumo glidewire, but encountered the same issue.Finally, the hcp successfully passed a 018 stiff command guidewire through the inner lumen and the lutonix dcb was advanced to the target lesion.The hcp noted difficulty passing the 018 guidewire through the hub of the lutonix dcb, specifically where the inner shaft interfaces with the hub.After treating the most distal portion of the target lesion, the hcp decided to use the lutonix dcb to treat the proximal portion of the target lesion, using two inflations of shorter duration.The hcp was unable to completely deflate the balloon after the devices third inflation.The hcp applied negative pressure, but the balloon did not completely deflate.The hcp then attempted to deflate it by using "double negative pressure," but was unsuccessful in deflating the balloon.Therefore, the hcp removed the introducer sheath and the lutonix dcb as a single unit.An observer of the procedure stated the hcp retracted the balloon back through a heavily diseased portion of the artery causing non-flow limiting dissections.The hcp completed the procedure by stenting the dissections.The lutonix dcb was returned for evaluation.No adverse patient outcomes 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
• MDR Report Key: 7531070
• MDR Text Key: 108846604
• Report Number: 3006513822-2018-00119
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741123245
• UDI-Public: (01)00801741123245
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFBY1837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 93