MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014; PTA BALLOON DILATATION CATHETER

Catalog Number	U4150515
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
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 will be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 03/2026).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 a very calcified vessel, the pta balloon allegedly detached inside of the patient and a snare was used to remove the detached segment.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 014 pta dilatation catheter was received for evaluation.During visual analysis, the distal tip of the balloon and inner guidewire lumen part were detached and not returned with the device could be observed.Further, a complete circumferential rupture could be observed in the distal end of the balloon and the ruptured balloon part was not received in returned sample.No other anomalies were noted.And due to the nature of complaint, further testing was not performed.The balloon catheter alone returned with out distal tip and portion of inner guidewire lumen noted to be detached.Further, a complete circumferential balloon rupture was noted in visual analysis.Therefore, the investigation was confirmed for the reported balloon detachment and identified balloon rupture.However, the functional testing could not be performed due to the device condition.Hence, the investigation was inconclusive for the reported difficult to remove balloon issue.A definitive root cause for the reported balloon detachment, difficult to remove balloon and identified balloon rupture issues 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: 03/2026), g3, h6 (device, method) h11: h6 (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 in the very calcified below knee vessel, the pta balloon had allegedly detached inside of the patient and a snare was used to remove the detached segment.It was further reported that the retained portion of the detached segment was successfully retrieved with a snare 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 ultraverse 014 pta dilatation catheter was returned to evaluation.On the visual evaluation could note the distal tip of the balloon was completely detached from the balloon distal end along the with the portion of inner guide wire lumen.The distal end of the balloon material has circumferential rupture due to the detachment of distal tip.The detached distal tip along with the inner guide wire lumen was also not returned to evaluation.No other anomalies noted and no functional testing performed due to the condition of device.The balloon catheter alone returned with out distal tip and portion of inner guidewire lumen noted to be detached.Further, a complete circumferential balloon rupture was noted in visual analysis.Therefore, the investigation was confirmed for the reported balloon detachment and identified balloon rupture.However, the functional testing could not be performed due to the device condition.Hence, the investigation was inconclusive for the reported difficult to remove balloon issue.A definitive root cause for the reported balloon detachment, difficult to remove balloon and identified balloon rupture issues 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 very calcified below knee vessel, the pta balloon had allegedly detached inside of the patient.Reportedly, a snare was used to remove the detached segment.There was no reported patient injury.

• Brand Name: ULTRAVERSE 014
• 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: 19131556
• Report Number: 2020394-2024-00534
• Device Sequence Number: 6891740
• Product Code: LIT
• UDI-Device Identifier: 00801741064562
• UDI-Public: (01)00801741064562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• 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,Followup
• Report Date (Section B): 05/13/2024

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: U4150515
• Device Lot Number: CMHR0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 05/13/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/09/2024; 05/17/2024
• 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