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

Model Number 9004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 05/20/2018

Event Type  Injury  

Manufacturer Narrative

Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.The investigation regarding the complaint has not been completed, a supplemental report will be provided with all relevant information.Conclusion: the actual samples were not received for evaluation.Once the investigation is completed, a supplemental report will be provided with all relevant information.

Event Description

It was reported through a clinical registry the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left superficial femoral artery(sfa).Approximately 20 months after the index procedure, the patient developed bilateral legs swelling for two days, as a result the patient underwent diagnostic testing via ultrasound exam.The result of the ultrasound was normal.After 3 additional months of observation, the patient has not improved and still experiences the symptoms.The investigator assessed that the event was possibly related to the study device.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2018-00260.

Event Description

It was reported through a clinical registry the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left mid-distal superficial femoral artery (sfa).Approximately 20 months after the index procedure, the patient developed bilateral leg swelling for two days, as a result the patient underwent diagnostic testing via an ultrasound exam.The result of the ultrasound was normal.After 3 additional months of observation, the patient's symptoms have not improved.The investigator assessed that the event was not related to the study devices.The investigator state the lutonix dcb's functioned normally and correctly during the index procedure.The samples were discarded by the user facility and are not available for evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2018-00260.

Manufacturer Narrative

Corrected data: the event description was updated with all relevant information from "it was reported through a clinical registry the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left superficial femoral artery(sfa).Approximately 20 months after the index procedure, the patient developed bilateral legs swelling for two days, as a result the patient underwent diagnostic testing via ultrasound exam.The result of the ultrasound was normal.After 3 additional months of observation, the patient has not improved and still experiences the symptoms.The investigator assessed that the event was possibly related to the study device.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2018-00260." to "it was reported through a clinical registry the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left mid-distal superficial femoral artery (sfa).Approximately 20 months after the index procedure, the patient developed bilateral leg swelling for two days, as a result the patient underwent diagnostic testing via an ultrasound exam.The result of the ultrasound was normal.After 3 additional months of observation, the patient's symptoms have not improved.The investigator assessed that the event was not related to the study devices.The investigator state the lutonix dcb's functioned normally and correctly during the index procedure.The samples were discarded by the user facility and are not available for evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2018-00260." the mdr contact person was changed from "(b)(6)" to "(b)(6)." mdr contact office was change from "(b)(4)" to "(b)(4)" the mdr contact person email address was changed from "(b)(6)" to "(b)(6)." the mdr contact person phone number was changed from "(b)(6)" to "(b)(6)." eval code & desc - conclusion changed code from "11" to "4310." additional data: manufacturing site added: (b)(4).Product catalog no.Added: 9050613500100.Serial no.Added: na.Expiry date added: 08/31/2017.Udi no.Added: (b)(4).Manufacturing date added: 09/10/2015 eval code & desc - method codes "4110,4111,3331" were added.Eval code & desc - conclusion code "22" was added.The analysis had the following information added: a lot history review revealed 1 additional bilateral leg swelling complaint associated with the same patient for this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Analysis conclusion: the analysis conclusion had the following information added: the dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed that the event was not related to the study devices.The investigator stated the lutonix dcb's functioned normally and correctly during the index procedure.Based on the instructions for use (ifu), the occurrence of swelling(i.E.Inflammation) is an inherent risk of any pta procedure.Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 1 additional bilateral leg swelling complaint associated with the same patient for this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual samples were not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed that the event was not related to the study devices.The investigator stated the lutonix dcb's functioned normally and correctly during the index procedure.Based on the instructions for use (ifu), the occurrence of swelling (i.E.Inflammation) is an inherent risk of any pta procedure.If additional information is obtained, a supplemental report will be provided with all relevant information.

• 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: 8057360
• MDR Text Key: 126888740
• Report Number: 3006513822-2018-00259
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 9004
• Device Catalogue Number: 9050613500100
• Device Lot Number: GFZH2963
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 74