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

Catalog Number	U35130515
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly difficult to remove over the wire and then through the sheath.It was further reported that it was inflated and then deflated completely.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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: 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 returned for evaluation.During visual evaluation, it was noted the balloon catheter was loaded onto sheath.The catheter shaft appeared to be stretched proximally from the sheath.No other anomalies were noted to the luers and y-body.During functional testing, negative pressure was applied to the balloon and pulled proximally to remove the balloon from the sheath.Balloon was not able to be removed without causing further stretching of the catheter and bunching of introducer sheath.No further testing could be performed due to the condition of the sample.Therefore, the investigation is confirmed for the reported for the sheath removal difficulty as the device was returned with a sheath loaded over the balloon and attempts to remove it were unsuccessful.Also, the investigation is confirmed for the identified stretched as stretching was noted to the catheter shaft.However, the investigation is inconclusive for the reported guidewire removal difficulty as guidewire testing could not be carried out due to condition of the sample received.A definitive root cause for the reported sheath removal difficulty, guidewire removal difficulty and identified stretched 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.G3, h6 (device, method, result, conclusion).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, the pta balloon was allegedly difficult to remove over the wire and then through the sheath.It was further reported that it was inflated and then deflated completely.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: 21812149
• Report Number: 2020394-2025-00536
• Device Sequence Number: 7350848
• Product Code: LIT
• UDI-Device Identifier: 00801741092725
• UDI-Public: (01)00801741092725(17)250531(10)CMGT0429
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/06/2025

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 Expiration Date: 05/31/2025
• Device Catalogue Number: U35130515
• Device Lot Number: CMGT0429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/19/2025
• 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