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

Model Number	US35130630
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was 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 instruction for use (ifu) is adequate for the reported device/patient 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.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure in the superficial femoral artery (sfa) with a focused force percutaneous transluminal angioplasty (pta) balloon, the patient had elastic recoil of the distal sfa.A pta balloon and drug-coated balloon were used for residual stenosis and to treat the elastic recoil.There current patient status was not provided.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted, and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was not returned, but medical records were provided.The case report form (crf) alleged elastic recoil after the use of the ultrascore, however the medical record review does not report the same outcome.Therefore, the investigation is inconclusive for the elastic recoil, as the provided evidence does not confirm the presence of elastic recoil or any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: g4 h11: b7, h6 (results 1) h11:section a through f - the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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 in the superficial femoral artery (sfa) with a focused force percutaneous transluminal angioplasty (pta) balloon, the patient had elastic recoil of the distal sfa.A pta balloon and drug-coated balloon were used for residual stenosis and to treat the elastic recoil.There current patient status was not provided.

• 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: 9276180
• Report Number: 2020394-2019-04365
• Device Sequence Number: 13926392
• Product Code: PNO
• UDI-Device Identifier: 00801741116926
• UDI-Public: (01)00801741116926
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 01/22/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: US35130630
• Device Catalogue Number: US35130630
• Device Lot Number: GFCN4121
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/22/2020
• 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: 76 YR
• Patient Weight: 107