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

Catalog Number	U420024RX
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
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.H11: section a through f: the information provide 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 dilatation catheter allegedly broke off in the patient when attempted to remove the balloon catheter.It was further reported that the catheter which was stuck inside the patient's body was removed.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the common femoral artery, the pta balloon allegedly broke off in the patient when attempted to remove it.It was further reported that the catheter which was stuck inside the patient's body was removed by using a balloon to push the catheter to the side of the sheath to trap it to the wall.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 rx dilatation catheter in two segments was received for evaluation.Upon visual inspection, a circumferential break was noted to the catheter, which consisted of two segments.One segment consisted of the distal end of the catheter and another segment consisted of the remaining proximal end of the catheter shaft and hub.No other anomalies were noted.No functional testing due to the condition of the device.One photo was received and reviewed.The photo shows ultraverse rx dilatation catheter in two segments.One segment with distal end of catheter and the other segment with proximal and of catheter shaft and hub.Therefore, the investigation is confirmed for the reported detachment issue as a circumferential break was noted to the catheter which returned in two segments.However, the investigation is inconclusive for the sheath removal difficulty as no functional testing was performed due to the condition of the device returned.A definitive root cause for the reported detachment and sheath removal difficulty 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: g3 h11: b5, h6 (method, result, conclusion) h11: section a through f: the information provide 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 RX
• 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: 20973791
• Report Number: 2020394-2024-01833
• Device Sequence Number: 19864116
• Product Code: LIT
• UDI-Device Identifier: 00801741056154
• UDI-Public: (01)00801741056154(17)270331(10)CMJR0326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• 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): 03/14/2025

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 Catalogue Number: U420024RX
• Device Lot Number: CMJR0326
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 03/19/2025
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG