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

Model Number	US35130610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Vascular Dissection (3160)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.No medical images have been made available to the manufacturer.Medical records were provided and reviewed and the investigation of the reported event is currently underway.Medical records review: the patient with critical limb ischemia of the right lower extremity was scheduled for intervention.An atherectomy of the entire superficial femoral artery (sfa) and peroneal artery was performed.Balloon angioplasty was then performed with 5 x 150, followed by a 6 x 150 and a 6 x 100 focused force balloons to treat a total length of 33 centimeters in the sfa.Prior to balloon angioplasty, intravascular ultrasound (ivus) revealed no dissections in the mid to distal sfa.There was an area of questionable dissection in the proximal sfa, but was not clearly defined and not visually present by angiography.Completion angiography as well as ivus did reveal an area of focal dissection of the proximal sfa which was likely an exacerbation of the previous dissection in this area.The decision was made to treat this with a 6 x 30 bare metal stent (bms).In the mid sfa, there was suboptimal angioplasty and required stenting with a 6 x 40 bms.Post dilatation was performed and ivus revealed resolution of the areas of concern.No complications were encountered.(manufacturing date: 03/2018).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 through the results of a clinical trial, that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the superficial femoral artery, vessel dissection was identified.Reportedly, the dissection was treated with a stent; completion imaging demonstrated resolution.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Medical records review: the patient with critical limb ischemia of the right lower extremity was scheduled for intervention.An atherectomy of the entire superficial femoral artery (sfa) and peroneal artery was performed.Balloon angioplasty was then performed with 5 x 150, followed by a 6 x 150 and a 6 x 100 focused force balloons to treat a total length of 33 centimeters in the sfa.Prior to balloon angioplasty, intravascular ultrasound (ivus) revealed no dissections in the mid to distal sfa.There was an area of questionable dissection in the proximal sfa, but was not clearly defined and not visually present by angiography.Completion angiography as well as ivus did reveal an area of focal dissection of the proximal sfa which was likely an exacerbation of the previous dissection in this area.The decision was made to treat this with a 6 x 30 bare metal stent (bms).In the mid sfa, there was suboptimal angioplasty and required stenting with a 6 x 40 bms.Post dilatation was performed and ivus revealed resolution of the areas of concern.No complications were encountered.Investigation summary: a sample evaluation could not be performed as the device was not returned.Medical records were provided and reviewed.Based on the provided medical records, 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.(manufacturing date: 03/2018).
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the superficial femoral artery, vessel dissection was identified.Reportedly, the dissection was treated with a stent; completion imaging demonstrated resolution.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the superficial femoral artery, vessel dissection was identified.Reportedly, the dissection was treated with a stent; completion imaging demonstrated resolution.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Medical records review: the patient with critical limb ischemia of the right lower extremity was scheduled for intervention.An atherectomy of the entire superficial femoral artery (sfa) and peroneal artery was performed.Balloon angioplasty was then performed with 5 x 150, followed by a 6 x 150 and a 6 x 100 focused force balloons to treat a total length of 33 centimeters in the sfa.Prior to balloon angioplasty, intravascular ultrasound (ivus) revealed no dissections in the mid to distal sfa.There was an area of questionable dissection in the proximal sfa, but was not clearly defined and not visually present by angiography.Completion angiography as well as ivus did reveal an area of focal dissection of the proximal sfa which was likely an exacerbation of the previous dissection in this area.The decision was made to treat this with a 6 x 30 bare metal stent (bms).In the mid sfa, there was suboptimal angioplasty and required stenting with a 6 x 40 bms.Post dilatation was performed and ivus revealed resolution of the areas of concern.No complications were encountered.Investigation summary: a sample evaluation could not be performed as the device was not returned.Medical records were provided and reviewed.Based on the provided medical records, 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.(manufacturing date: 03/2018).
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Medical records review: the patient with critical limb ischemia of the right lower extremity was scheduled for intervention.An atherectomy of the entire superficial femoral artery (sfa) and peroneal artery was performed.Balloon angioplasty was then performed with 5 x 150, followed by a 6 x 150 and a 6 x 100 focused force balloons to treat a total length of 33 centimeters in the sfa.Prior to balloon angioplasty, intravascular ultrasound (ivus) revealed no dissections in the mid to distal sfa.There was an area of questionable dissection in the proximal sfa, but was not clearly defined and not visually present by angiography.Completion angiography as well as ivus did reveal an area of focal dissection of the proximal sfa which was likely an exacerbation of the previous dissection in this area.The decision was made to treat this with a 6 x 30 bare metal stent (bms).In the mid sfa, there was suboptimal angioplasty and required stenting with a 6 x 40 bms.Post dilatation was performed and ivus revealed resolution of the areas of concern.No complications were encountered.Investigation summary: a sample evaluation could not be performed as the device was not returned.Medical records were provided and reviewed.Based on the provided medical records, 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 with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the superficial femoral artery, vessel dissection was identified.Reportedly, the dissection was treated with a stent; completion imaging demonstrated resolution.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the superficial femoral artery, vessel dissection was identified.Reportedly, the dissection was treated with a stent; completion imaging demonstrated resolution.New information: approximately 9 months post index procedure, restenosis was present and intervention was performed, reducing the diameter stenosis from 55.6% to 25%.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Medical records review: the patient with critical limb ischemia of the right lower extremity was scheduled for intervention.An atherectomy of the entire superficial femoral artery (sfa) and peroneal artery was performed.Balloon angioplasty was then performed with 5 x 150, followed by a 6 x 150 and a 6 x 100 focused force balloons to treat a total length of 33 centimeters in the sfa.Prior to balloon angioplasty, intravascular ultrasound (ivus) revealed no dissections in the mid to distal sfa.There was an area of questionable dissection in the proximal sfa, but was not clearly defined and not visually present by angiography.Completion angiography as well as ivus did reveal an area of focal dissection of the proximal sfa which was likely an exacerbation of the previous dissection in this area.The decision was made to treat this with a 6 x 30 bare metal stent (bms).In the mid sfa, there was suboptimal angioplasty and required stenting with a 6 x 40 bms.Post dilatation was performed and ivus revealed resolution of the areas of concern.No complications were encountered.Investigation summary: a sample evaluation could not be performed as the device was not returned.Medical records were provided and reviewed.Based on the provided medical records, 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 with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the superficial femoral artery, vessel dissection was identified.Reportedly, the dissection was treated with a stent; completion imaging demonstrated resolution.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Medical records review: the patient with critical limb ischemia of the right lower extremity was scheduled for intervention.An atherectomy of the entire superficial femoral artery (sfa) and peroneal artery was performed.Balloon angioplasty was then performed with 5 x 150, followed by a 6 x 150 and a 6 x 100 focused force balloons to treat a total length of 33 centimeters in the sfa.Prior to balloon angioplasty, intravascular ultrasound (ivus) revealed no dissections in the mid to distal sfa.There was an area of questionable dissection in the proximal sfa, but was not clearly defined and not visually present by angiography.Completion angiography as well as ivus did reveal an area of focal dissection of the proximal sfa which was likely an exacerbation of the previous dissection in this area.The decision was made to treat this with a 6 x 30 bare metal stent (bms).In the mid sfa, there was suboptimal angioplasty and required stenting with a 6 x 40 bms.Post dilatation was performed and ivus revealed resolution of the areas of concern.No complications were encountered.Investigation summary: a sample evaluation could not be performed as the device was not returned.Medical records were provided and reviewed.Based on the provided medical records, 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.H10: b6; g4 h11: g1 h11:section a through f - the information provided by bd 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 bd.

• 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: 7684298
• Report Number: 2020394-2018-01186
• Device Sequence Number: 13802377
• Product Code: PNO
• UDI-Device Identifier: 00801741116872
• UDI-Public: (01)00801741116872
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/29/2020

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: 02/28/2020
• Device Model Number: US35130610
• Device Catalogue Number: US35130515
• Device Lot Number: GFCN4104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 01/15/2019; 04/16/2019; 12/24/2019; 01/28/2020
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/30/2018; 02/11/2019; 04/23/2019; 01/02/2020; 01/29/2020
• 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 Age: 81 YR
• Patient Weight: 64