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

Model Number U3575106

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

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 been returned to the manufacturer for evaluation as well as a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2023).

Event Description

It was reported that prior to an angioplasty procedure, the catheter of the device was allegedly found to be broken.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse 035 pta dilatation catheter has returned for evaluation.A kink was able to note on the catheter, no specific damage noted on the returned device.No further testing performed due to the nature of the complaint.All the anomalies noted under the microscopic observation.One photo was reviewed.The photo shows the catheter which have a kink, no other evidence of catheter damage or break noted.Therefore, based on the photo review the reported break was unconfirmed as there is no evidence specific damage noted.However, catheter kink was able to be identified and can be confirmed based on the submitted photo.Therefore, the investigation for the reported break was unconfirmed as there is no break noted on the returned device for evaluation.However, the investigation was confirmed for material deformation as kink was able to be noted on the catheter returned for evaluation.A definitive root cause for the reported break and identified catheter kink could not be determined based upon the provided information.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: b5, d4 (expiry date: 07/2023), g3, h6 (device, method).H11: h6 (result, conclusion).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 Description

It was reported that prior to an angioplasty procedure, the catheter of the device was allegedly found to be broken.The procedure was completed by using another device.There was no patient contact.

• Brand Name: ULTRAVERSE 035 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12531241
• MDR Text Key: 273309215
• Report Number: 2020394-2021-01800
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741094590
• UDI-Public: (01)00801741094590
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U3575106
• Device Catalogue Number: U3575106
• Device Lot Number: CMEV0396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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