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

Model Number U35130630

Device Problems Break (1069); Inflation Problem (1310); Material Twisted/Bent (2981)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure in right superficial femoral artery through contralateral approach, the pta balloon was seemed to be allegedly twisted while in the patient.It was further reported that while inflating to nominal pressure, there was one centimeter segment which was not dilated.Reportedly, the balloon was re positioned to post dilate the segment that was noticed as not dilated and the procedure was completed successfully.There was no reported patient injury.

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.The investigation of the reported event is currently underway.(expiry date: 06/2025).

Event Description

It was reported that during an angioplasty procedure in the right superficial femoral artery through contralateral approach, the pta balloon was seemed to be allegedly twisted while in patient.It was further reported that while inflating to nominal pressure, there was one centimeter segment which was not dilated.Reportedly, the balloon was re positioned to post dilate the segment that was noticed as not dilated and the procedure was completed successfully.There was no reported patient injury.

Manufacturer Narrative

H10: the initial mdr was inadvertently submitted with a g3 date of 02/15/2023.The correct g3 date is 02/14/2023.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: one ultraverse 035 pta dilatation catheter was returned for evaluation.Balloon was noted to be twisted throughout the length; no other specific anomalies noted on visual evaluation.On functional testing, the returned balloon was inflated with an in-house presto inflation device and water was noted to be leaking from the guide wire lumen; upon further evaluation, a partial circumferential break on the catheter was noted.The balloon was cut and the inflation ports were noted to be collapsed, all the anomalies were observed under the microscopic observation.No further testing is performed.Therefore, the investigation is confirmed for the reported balloon twist upon inflation as the balloon was noted to be twisted through the length which was able to be noted during visual evaluation and also the inflation port hole was also note to be collapsed under microscopic observation.The investigation is also confirmed for the identified catheter break as during the functional testing a partial circumferential break on the catheter was observed.Under the microscopic observation the inflation port holes was noted to be collapsed might have caused the reported inflation issue.However the definitive root cause for the reported balloon twist upon inflation and identified catheter break 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: (expiry date: 06/2025).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.

• 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: 16730482
• MDR Text Key: 313192454
• Report Number: 2020394-2023-00246
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741093258
• UDI-Public: (01)00801741093258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U35130630
• Device Catalogue Number: U35130630
• Device Lot Number: CMGU0353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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