MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018; PTA BALLOON DILATATION CATHETER

Catalog Number	U8150315
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
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.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2026).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 in the superficial femoral artery via the common femoral artery, the balloon allegedly failed to advance.It was further reported that the balloon allegedly can no longer be retracted in the blood vessel.Reportedly, the surgeon chooses to withdraw the balloon and guidewire as a whole.The procedure was completed using another device.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 photo was received and reviewed.The photo shows the ultraverse 018 in its packaging cover.The labeling details present on the cover matches with the details present in trackwise.No other anomalies noted.One ultraverse 018 was returned for evaluation.During visual evaluation, an unknown brand guidewire was loaded to the catheter and the strain relief was noted to be separated from the catheter shaft.Further, bunching was noted to the proximal end of the catheter shaft and also bunching and slight twisting were noted to the balloon.Additionally, the balloon was noted to be inverted at the distal end.An attempt was made to retrieve the unknown guidewire from the ultraverse 018 but it was unsuccessful.Heavy resistance was felt due to the bunching on the catheter shaft below the strain relief.No further testing performed.Therefore, the investigation is confirmed for the reported guidewire advancement failure as the device was returned with loaded guidewire and retrieval of the guidewire was unsuccessful in the functional testing.Also, the investigation is confirmed for the identified material deformation and material twist as the balloon was noted to have inversion, bunching and slight twist.Additionally, the investigation is confirmed for the identified device dislodged as the strain relief was noted to be separated from the catheter shaft.A definitive root cause for the reported guidewire advancement failure, identified material deformation, material twist and device dislodged 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.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 in the superficial femoral artery via the common femoral artery, the pta balloon allegedly failed to advance.It was further reported that the balloon allegedly can no longer be retracted in the blood vessel.Reportedly, the surgeon chooses to withdraw the balloon and guidewire as a whole.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 018
• 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: 20394236
• Report Number: 2020394-2024-01547
• Device Sequence Number: 12403601
• Product Code: LIT
• UDI-Device Identifier: 00801741064906
• UDI-Public: (01)00801741064906(17)260131(10)CMHP0144
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121856
• 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): 02/20/2025

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: 01/31/2026
• Device Catalogue Number: U8150315
• Device Lot Number: CMHP0144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 02/21/2025
• 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