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

Catalog Number	U415024RX
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an angioplasty procedure in the tibial vessel via groin access, the pta balloon dilatation catheter allegedly broke off in the patient when attempted to remove the balloon catheter from the patient.It was further reported that the catheter was broken into two segments and it was difficult to remove from the patient.Patient was taken to surgery to complete the procedure.The current status of the patient in unknown.
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.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.H3 other text : device pending return.
Event or Problem Description
It was reported that during an angioplasty procedure in the tibial vessel via groin access, the pta balloon dilatation catheter allegedly broke off in the patient when attempted to remove the balloon catheter from the patient.It was further reported that the catheter was broken into two segments and it was difficult to remove from the patient.Patient was taken to surgery to complete the procedure.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ultraverse rx pta dilatation catheter in two segments was returned for evaluation.On the visual evaluation, the first segment consists of the portion of the inflation hub and consists of part of the catheter, the second part consists of the remaining detached catheter along with the inner guide wire lumen and balloon.The returned device had multiple kinks along the length of the returned catheter.No functional testing could be performed due to the condition of the balloon.As the balloon was returned in two detached segments for evaluation and no objective evidence for balloon removal difficulty couldn¿t be observed and functional testing couldn¿t be performed due to its condition.Hence the investigation was confirmed for the reported balloon detachment and the investigation remains inconclusive to the reported balloon removal difficulty.A definitive root cause for the reported balloon detachment and balloon 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: (expiry date: 09/2024).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.

• 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: 17600757
• Report Number: 2020394-2023-00591
• Device Sequence Number: 15029494
• Product Code: LIT
• UDI-Device Identifier: 00801741056147
• UDI-Public: (01)00801741056147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: U415024RX
• Device Lot Number: CMFX0355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown