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

Catalog Number	U35130128
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure for inferior vena cava stenosis and in-stent restenosis in iliac vein via femoral vein, the pta balloon allegedly burst in the body of the patient suddenly when the pressure was increased to 6 atm.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 08/2025).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.H3 other text : device pending return.
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 pta dilatation catheter was returned and evaluated.Compound balloon rupture was noted and no other anomalies were noted during the visual examination.No functional testing was performed due to conditions of the device.As the compound rupture was noted during the visual examination and no functional testing was performed due to the device's condition, the investigation was confirmed for the reported balloon rupture and the investigation remains inconclusive about the reported balloon difficulty removing the sheath.A definitive root cause for the reported balloon rupture and balloon difficulty removing the sheath could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 08/2025), g3.H11: h6 (method, result, conclusion).H11: section a through f ¿ 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 for inferior vena cava stenosis and in-stent restenosis in the iliac vein via the femoral vein, the pta balloon allegedly burst in the body of the patient suddenly when the pressure was increased to 6 atm.It was further reported that there was difficulty in retracting the balloon through the introducer sheath following the balloon rupture and were retrieved as one unit.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the fda rn number for the initial mdr was inadvertently submitted as 3006260740.The correct fda rn number was (b)(4).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 pta dilatation catheter was returned and evaluated.Compound balloon rupture was noted and no other anomalies were noted during the visual examination.No functional testing was performed due to conditions of the device.As the compound rupture was noted during the visual examination and no functional testing was performed due to the device's condition, the investigation was confirmed for the reported balloon rupture and the investigation remains inconclusive about the reported balloon difficulty removing the sheath.A definitive root cause for the reported balloon rupture and balloon difficulty removing the sheath could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 08/2025).H11: section a through f ¿ 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 for inferior vena cava stenosis and in-stent restenosis in the iliac vein via the femoral vein, the pta balloon allegedly burst in the body of the patient suddenly when the pressure was increased to 6 atm.It was further reported that there was difficulty in retracting the balloon through the introducer sheath following the balloon rupture and were retrieved as one unit.The procedure was completed using another device.There was no reported patient 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: 17689750
• Report Number: 3006260740-2023-03921
• Device Sequence Number: 12270151
• Product Code: LIT
• UDI-Device Identifier: 00801741094965
• UDI-Public: (01)00801741094965
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 01/10/2024

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 Catalogue Number: U35130128
• Device Lot Number: CMGW0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 01/10/2024
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 12/01/2023; 01/10/2024
• 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