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

Model Number U3513066

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2024).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly detached and fell into the heart.It was further reported the catheter was removed from the body.The procedure was completed using another device.The current status of the patient is unknown.

Manufacturer Narrative

Additional information was received and 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.D4 (expiry date: 10/2024).H11: section a through f: 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 Description

It was reported that during an angioplasty procedure, the catheter allegedly had a kink.It was further reported that the guidewire allegedly failed to advance through the catheter.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 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): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17001145
• MDR Text Key: 315908554
• Report Number: 2020394-2023-00366
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741093180
• UDI-Public: (01)00801741093180
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/08/2023

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
• Device Operator: Health Professional
• Device Model Number: U3513066
• Device Catalogue Number: U3513066
• Device Lot Number: CMFY0449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention