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

Catalog Number	U35130530
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly unable to be removed from sheath after inflation.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 (expiry date: 12/2025).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.H3 other text : device pending return.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly unable to be removed from the sheath after inflation.There was no reported patient 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 device was returned for evaluation with an unknown brand sheath loaded over the balloon.Kinks and bends were noted throughout the catheter shaft.Bunching was noted throughout the balloon and sheath.Kinks were also noted to the inner guidewire lumen.Complete circumferential rupture was noted to the balloon.An attempt was made to remove the sheath from the balloon, but it was unsuccessful.No further testing was performed.Therefore, the investigation is confirmed for the sheath removal difficulty as the device was returned with a sheath loaded over the balloon and attempts to remove it were unsuccessful.The investigation is also confirmed for the identified material deformation as kinks, bends and bunching were noted throughout the device.The investigation is also confirmed for the identified circumferential rupture as a complete circumferential rupture was noted to the balloon.A definitive root cause for the reported sheath removal difficulty, identified material deformation and circumferential rupture 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: 12/2025), g3, h6 (device).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.

• 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: 19076970
• Report Number: 2020394-2024-00474
• Device Sequence Number: 6030587
• Product Code: LIT
• UDI-Device Identifier: 00801741092756
• UDI-Public: (01)00801741092756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/01/2024

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: U35130530
• Device Lot Number: CMHN0296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/12/2024
• 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