MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 035; PTA BALLOON DILATATION CATHETER

Model Number US35130610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

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, 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: 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.(expiry date: 02/2020).

Event Description

It was reported through the results of a clinical trial that same day post index procedure, there was a spiral dissection and the outcome of adverse event was possibly related to device and definitely related to procedure.A percutaneous transluminal angioplasty (pta) drug coated balloon (dcb) and bare metal stent were used to successfully treat the target lesion.The current patient status was not provided.

• Brand Name: ULTRASCORE 035
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12621206
• MDR Text Key: 276114684
• Report Number: 2020394-2021-01861
• Device Sequence Number: 1
• Product Code: PNO
• UDI-Device Identifier: 00801741116872
• UDI-Public: (01)00801741116872
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US35130610
• Device Catalogue Number: US35130610
• Device Lot Number: GFCN4106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASPIRIN AND CLOPIDOGREL
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 113