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

Model Number	US35130530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Stenosis (2263); Vascular Dissection (3160)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 08/2020), (manufacturing date: 09/2018).
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 (pta) balloon dilatation catheter, vessel dissection was identified after one inflation in the right superficial femoral artery.Reportedly, the dissection was treated with a bare metal stent.The event was considered to be resolved.The subject was discharged one day after the index procedure.
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 (pta) balloon dilatation catheter, vessel dissection was identified after one inflation in the right superficial femoral artery.Reportedly, the dissection was treated with a bare metal stent.The event was considered to be resolved.The subject was discharged same day.
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 for evaluation.Images and medical records were not provided for review.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.(expiry date: 08/2020), (manufacturing date: 09/2018).
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 (pta) balloon dilatation catheter, vessel dissection was identified after one inflation in the right superficial femoral artery.Reportedly, the dissection was treated with a bare metal stent.The event was considered to be resolved.The subject was discharged same day.New information: it was reported through the results of a clinical trial, stenosis at the target lesion was identified via duplex ultrasound on (b)(6) 2019.
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 for evaluation.Images and medical records were not provided for review.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.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.
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 (pta) balloon dilatation catheter, vessel dissection was identified after one inflation in the right superficial femoral artery.Reportedly, the dissection was treated with a bare metal stent.The event was considered to be resolved.The subject was discharged same day.New information: it was reported through the results of a clinical trial, stenosis at the target lesion was identified via duplex ultrasound on (b)(6)2019.New information: it was reported through the results of a clinical trial approximately 12-month post index procedure, occlusion was identified via duplex ultrasound.
Additional Manufacturer Narrative
H10: 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 for evaluation.Images and medical records were not provided for review.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.H10: b5, b6, g4 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: 8189642
• Report Number: 2020394-2018-02247
• Device Sequence Number: 1997520
• Product Code: PNO
• UDI-Device Identifier: 00801741116827
• UDI-Public: (01)00801741116827
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/08/2020

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 Model Number: US35130530
• Device Catalogue Number: US35130530
• Device Lot Number: GFCV0689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/16/2019; 11/05/2019; 01/06/2020
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/11/2019; 11/06/2019; 01/08/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 109