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

Model Number	U357564
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional 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.Expiration date: 04/2025.The information provided 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 or Problem Description
It was reported that during an angioplasty procedure, the pta balloon catheter allegedly leaked contrast upon inflation at 12 atm.It was further reported that the balloon was deflated and re-inflated, same thing allegedly happened.Reportedly, the balloon was removed and rinsed off and it was inflated once again and balloon allegedly leaked.The procedure was completed using another device.There was no reported patent injury.
Additional 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 dilatation catheter was returned for evaluation.No other specific anomalies were noted during the visual evaluation.During functional testing, the balloon was inflated with an in-house presto inflation device and water was noted to be leaking from the distal tip.The balloon fibers were stripped and a partial circumferential break was observed within the inner guide wire lumen.No other functional testing was performed.All the anomalies are noted by microscopic observation.Therefore, the investigation is confirmed for the reported leak as the catheter noted leakage upon inflating the balloon during functional testing of the returned device.The investigation is also confirmed for the identified inner guide wire lumen tear, as a partial circumferential break was noted on the inner guide wire lumen upon microscopic observation.A definitive root cause for the reported leak and identified inner guide wire lumen tear 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: d4 (expiration date: 04/2025), g3, h6 (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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon catheter allegedly leaked contrast upon inflation at 12 atm.It was further reported that the balloon was deflated and re-inflated, same thing allegedly happened.Reportedly, the balloon was removed and rinsed off and it was inflated once again and balloon allegedly leaked.The procedure was completed using another device.There was no reported patent injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15977493
• Report Number: 2020394-2022-00985
• Device Sequence Number: 12227002
• Product Code: LIT
• UDI-Device Identifier: 00801741092954
• UDI-Public: (01)00801741092954
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: U357564
• Device Catalogue Number: U357564
• Device Lot Number: CMGS0526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 12/27/2022
• 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 Age: 59 YR
• Patient Sex: Unknown
• Patient Race: Black Or African American