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

Model Number	US14150330
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
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 (01/2021) the information provide by bd represents all 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 approximately twenty three days post index procedure, angiography demonstrated target lesion stenosis.Pta (non dcb) was used to successfully treat the target lesion.The current patient status was not provided.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a serious injury.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b7, d4 (expiry date: 01/2021), g3, h6 (method).H11: b3, b5, h6 (patient, device).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 approximately twenty three days post index procedure, angiography demonstrated new lesion stenosis.Pta (non dcb) was used to successfully treat the new lesion.The current patient status was not provided.

• Brand Name: ULTRASCORE FOCUSED FORCE PTA BALLOON
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10745925
• Report Number: 2020394-2020-20281
• Device Sequence Number: 14316999
• Product Code: PNO
• UDI-Device Identifier: 00801741113550
• UDI-Public: (01)00801741113550
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: US14150330
• Device Catalogue Number: US14150330
• Device Lot Number: GFDN2623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN.; ASPIRIN.; ASPIRIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 57