MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE FOCUSED FORCE PTA BALLOON

Model Number	US35130412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Vascular Dissection (3160)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the subject with history of right lower extremity non-healing wound of the forefoot was scheduled for balloon angioplasty of the popliteal and superficial femoral artery followed by drug-coated balloon angioplasty.The proximal superficial femoral artery was accessed and diagnostic images demonstrated a diseased sfa with in-tandem stenosis, 50% to 70% occlusion of the entire popliteal artery.A guidewire and catheter were used to cross the chronic total occlusion and small balloon dilations were performed by going up 2mm to create adequate facing.There was a traumatic fistula of the popliteal artery, as well as inadequate expansion with a smaller balloon.A drug-coated balloon was used in the popliteal artery.A stent was implanted given the elastic recoil.The proximal sfa was then further treated with the drug-coated balloon with good success.A closure device was used at the completion of the procedure.The subject was stable throughout the procedure.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure in the popliteal artery with a focused forced percutaneous transluminal angioplasty (pta) balloon dilatation catheter, following use of the study device, a fistula of the popliteal artery was identified.The target lesion was treated with drug-coated balloon angioplasty followed by stent placement.The current patient status was not provided.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure in the popliteal artery with a focused forced percutaneous transluminal angioplasty (pta) balloon dilatation catheter, following use of the study device, a fistula of the popliteal artery was identified.The target lesion was treated with drug-coated balloon angioplasty followed by stent placement.The current patient status was not provided.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was not returned, but medical records were provided.Based on the medical records, the occurrence of a fistula was confirmed, but is unknown if the fistula is related to the ultrascore pta balloon used and the procedure.Therefore the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was not returned, but medical records were provided.Based on the medical records, the occurrence of a fistula was confirmed, but is unknown if the fistula is related to the ultrascore pta balloon used and the procedure.Therefore the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure in the popliteal artery with a focused forced percutaneous transluminal angioplasty (pta) balloon dilatation catheter, following use of the study device, a fistula of the popliteal artery was identified.The target lesion was treated with drug-coated balloon angioplasty followed by stent placement.The current patient status was not provided.New information: it was reported through the results of a clinical trial that following angioplasty procedure in the popliteal artery with a focused force percutaneous transluminal angioplasty (pta) balloon dilatation catheter, final imaging identified dissection.The current status of the patient is unknown.

• Brand Name: ULTRASCORE FOCUSED FORCE PTA BALLOON
• Common Device Name: FOCUSED FORCE PTA BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8066821
• Report Number: 2020394-2018-02017
• Device Sequence Number: 19508511
• Product Code: PNO
• UDI-Device Identifier: 00801741116681
• UDI-Public: (01)00801741116681
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2019

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: 06/28/2020
• Device Model Number: US35130412
• Device Catalogue Number: US35130412
• Device Lot Number: GFCR2847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 01/30/2019; 05/09/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 02/05/2019; 06/05/2019
• 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
• Patient Weight: 66