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

Model Number	9004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	08/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt, visual examination of the returned device was performed which revealed a circumferential material rupture at the distal third of the balloon.In addition, a longitudinal tear from the distal third of the balloon to the proximal bond.The distal half of the balloon was not present.The peel away balloon protector was not removed and remained on the catheter shaft.The balloon protector was just below the strain relief of the hub.A lot history review revealed this is the only complaint 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: there was nothing found to indicate there was a manufacturing related cause for this event.Although requested, the target lesion and pathway to the target lesion morphology are not available.Further investigation of the device is in progress.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 ruptured at six atmospheres in the distal popliteal artery.Reportedly, the catheter was removed and it appeared that the material rupture was circumferential.Diagnostic imaging was performed, which revealed the distal half of the balloon was still in the patient.The health care professional (hcp) performed a cutdown to the popliteal artery to retrieve the distal portion of the balloon.The hcp successfully retrieved all of the balloon remnants from the patient's vessel.The patient recovered from the procedure and the surgical cutdown.The lutonix dcb was returned for further evaluation.Images of the lutonix dcb were also obtained for review.No further adverse patient effects were reported.
Additional Manufacturer Narrative
(b)(4).Analysis/device evaluation: upon receipt, visual examination of the returned device was performed which revealed the distal half of the balloon was not present.The remaining portion of the balloon on the catheter measured 47mm.Furthermore, this remaining portion of the balloon was longitudinally ruptured, which extended from the proximal balloon bond to the alleged circumferential tear.Lutonix tried to replicate circumferential ruptures in the lab by performing burst testing of 3 samples with the same balloon length.These test balloons did burst longitudinally at 22-24 atmospheres(atm), which is above the recommended rated burst pressure of 12-15 atm.Further, 2 samples were sent for evaluation to an independent lab utilizing a scanning electron microscope (sem).The sem results of the two samples were compared which revealed sample 1 appears to have ruptured longitudinally from the proximal to distal balloon bonds.The balloon appeared to have torn circumferentially during removal, likely due to the inability to apply negative pressure during removal of the catheter from the patient.The peel away balloon protector was not removed and remained on the catheter shaft.The balloon protector was just below the strain relief of the hub.A lot history review revealed this is the only complaint 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: returned device analysis was unable to confirm the balloon ruptured circumferentially.Based on the information from the complainant and the device analysis results, the material rupture appears to be longitudinal from proximal to distal balloon bond with the distal half of the balloon being torn during the retraction of the catheter from the patient.Although requested, it is unknown if the target lesion morphology and/or tracking pathway was calcified and/or tortuous or if the hcp predilated the target lesion.There was nothing found to indicate there was a manufacturing related cause for this event.A review of the lutonix quality system did not identify any trends for the circumferential balloon rupture event.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 ruptured at six atmospheres in the distal popliteal artery.Reportedly, the catheter was removed and it appeared that the material rupture was circumferential.Diagnostic imaging was performed, which revealed the distal half of the balloon was still in the patient.The health care professional (hcp) performed a cutdown to the popliteal artery to retrieve the distal portion of the balloon.The hcp successfully retrieved all of the balloon remnants from the patient's vessel.The patient recovered from the procedure and the surgical cutdown.The lutonix dcb was returned for further evaluation.Images of the lutonix dcb were also obtained for review.No further 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: 5939222
• Report Number: 3006513822-2016-00177
• Device Sequence Number: 1509599
• Product Code: ONU
• UDI-Device Identifier: 00801741088353
• UDI-Public: (01)00801741088353(17)171231(10)GFZL0621
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2016

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: 12/31/2017
• Device Model Number: 9004
• Device Catalogue Number: 9020410500080
• Device Lot Number: GFZL0621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• 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: 09/09/2016
• Supplement Report FDA Received Date: 10/26/2016
• 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