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

Model Number	U357554
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional 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 035 pta dilatation catheter was returned for evaluation.No specific anomalies noted during the visual evaluation.On the functional evaluation, an in-house syringe was used to run water through the inflation luer and water was noted to be leaking under the strain relief.The strain relief was removed and once again the water was streaming from the proximal end of the y-body.Under microscopic observation it was noted a partial circumferential break at the proximal bond joint of the catheter and y-body.No other functional testing was performed.Therefore, the investigation for the reported leak was confirmed as the device leaks from the strain relief during the functional testing.The investigation was also confirmed for the identified bond joint break as partial circumferential break at the proximal bond joint of the catheter and y-body observed under microscopic observation.During the microscopic observation it was noted a partial circumferential break at the proximal bond joint of catheter and y-body which might lead to the reported leak.A definitive root cause for the reported leak and identified bond joint 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.(expiry date: 02/2024).
Event or Problem Description
It was reported that prior to an angioplasty procedure, leak occurred at the proximal hub, where the catheter meets the y-connector upon inflating the balloon.The procedure was completed using another device.There was no patient contact.

• Brand Name: ULTRAVERSE 035
• Common Device Name: 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: 13903587
• Report Number: 2020394-2022-00225
• Device Sequence Number: 14528862
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: U357554
• Device Catalogue Number: U357554
• Device Lot Number: CMFQ0265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown