MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014; PTA BALLOON DILATATION CATHETER

Model Number U41502H22

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

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 014 pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted bloody and the balloon along with the distal portion of the inner guidewire lumen got detached and not returned for the evaluation.The detachment was noted to the catheter shaft just proximal to the proximal end of the balloon.The inner guide-wire lumen was exposed and noted stretched.The proximal marker band was noted to be present.No other functional testing was performed due to the condition of the returned device.Therefore the investigation for the reported balloon rupture remains inconclusive, as the functional testing was not performed due to the condition of the returned device.The investigation for the identified detachment of device or device component was confirmed, as the balloon along with the distal portion of the inner guidewire lumen got detached and not returned for the evaluation.A definitive root cause for the reported balloon rupture and the identified detachment of device or device component 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.Expiry date: 07/2023.

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly had a rupture.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 014
• 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: 12662793
• MDR Text Key: 277392008
• Report Number: 2020394-2021-01892
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741053658
• UDI-Public: (01)00801741053658
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U41502H22
• Device Catalogue Number: U41502H22
• Device Lot Number: CMEV0198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/20/2021
• 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