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

Model Number 9004

Device Problems Kinked (1339); Material Rupture (1546); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter, which revealed a kink in both the balloon and inner shaft at the proximal end of the catheter.Functional testing was performed by inflating the balloon which revealed a material rupture in the middle of the balloon.A lot history review revealed this is the only complaint from this lot associated with an allegation of balloon rupture.A device history record (dhr) was reviewed for this device.A review of the manufacturing record indicates the lot was manufactured to specification.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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured prior to reaching 6 atmospheres(atms) at the target lesion.The health care professional (hcp) used an ipselateral approach to treat the superficial femoral artery (sfa).The hcp reportedly predilated the target lesion.The vessel morphology and lesion were not calcified or tortuous.Reportedly, no stents had previously been placed in the vessel.The hcp reached the target lesion and attempted the first inflation of the balloon.Reportedly, prior to reaching 6 atms, the balloon allegedly ruptured.The hcp removed the ruptured balloon in its entirety and used another lutonix dcb to complete the procedure.In the hcp's opinion, the anatomy and or vessel morphology did not contribute to the balloon rupture.The lutonix dcb was returned for evaluation.No adverse patient outcomes were reported.

Manufacturer Narrative

Other relevant history was changed from "unknown" to "although requested, patient demographics were unavailable." (b)(4).Analysis/device evaluation was updated with the following: "which revealed a kink in both the balloon and inner shaft approximately 55mm from the proximal balloon bond.The distal end of the balloon was wrinkled.Functional testing was performed by applying negative pressure which could not be maintained.The balloon was attempted to be inflated to 8 atmospheres (atms), but pressure was unable to be maintained due to solution coming from a material rupture, identified in the middle of the balloon.The material rupture was approximately 76mm from the proximal balloon bond.Under microscopic evaluation, a small hole was detected within a scratch, found under a fold of the balloon." analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter, which revealed a kink in both the balloon and inner shaft approximately 55mm from the proximal balloon bond.The distal end of the balloon was wrinkled.Functional testing was performed by applying negative pressure which could not be maintained.The balloon was attempted to be inflated to 8 atmospheres (atms), but pressure was unable to be maintained due to solution coming from a material rupture, identified in the middle of the balloon.The material rupture was approximately 76mm from the proximal balloon bond.Under microscopic evaluation, a small hole was detected within a scratch, found under a fold of the balloon.A lot history review revealed this is the only complaint from this lot associated with an allegation of balloon rupture.A device history record (dhr) was reviewed for this device.A review of the manufacturing record indicates the lot was manufactured to specification.Conclusion: returned product analysis confirmed the material rupture to be a small hole within a scratch found under a fold of the balloon.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause could not be determined based on the information provided.It is unknown if the 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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured prior to reaching 6 atmospheres(atms) at the target lesion.The health care professional (hcp) used an ipslateral approach to treat the superficial femoral artery (sfa).The hcp reportedly predilated the target lesion.The vessel morphology and lesion were not calcified or tortuous.Reportedly, no stents had previously been placed in the vessel.The hcp reached the target lesion and attempted the first inflation of the balloon.Reportedly, prior to reaching 6 atms, the balloon allegedly ruptured.The hcp removed the ruptured balloon in its entirety and used another lutonix dcb to complete the procedure.In the hcp's opinion, the anatomy and/or vessel morphology did not contribute to the balloon rupture.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
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: john risse ; 9409 science center dr; new hope, MN 55428 ; 7634632917
• MDR Report Key: 6770286
• MDR Text Key: 81927293
• Report Number: 3006513822-2017-00150
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088766
• UDI-Public: (01)00801741088766
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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: 01/31/2018
• Device Model Number: 9004
• Device Catalogue Number: 9080413600150
• Device Lot Number: GFAN1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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